Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
- Registration Number
- NCT00263328
- Lead Sponsor
- Pfizer
- Brief Summary
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus)
- Recipient of a first-time kidney transplant
- Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
- Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group 3 CP-690,550 Treatment group 3 does not receive mycophenolate mofetil Treatment group 2 CP-690,550 Treatment group 2 also receives mycophenolate mofetil Treatment group 1 Tacrolimus Standard of care
- Primary Outcome Measures
Name Time Method Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 \* (serum creatinine \[in milligrams per deciliter (mg/dL)\])\^(-0.999) \* (age in years)\^(-0.176) \* (0.762 if female) \* (1.18 if black) \* (blood urea nitrogen \[BUN\] concentration \[mg/dL\])\^(-0.170) \* (serum albumin concentration \[in grams per dL (g/dL)\])\^(0.318). A normal GFR is \>90 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min/1.73 m\^2 indicated kidney failure.
Serum Creatinine Levels Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (≥)30 days.
Percentage of Participants With Hypertriglyceridemia by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Hypertriglyceridemia was defined as triglyceride levels of \>200 mg/dL or 2.3 mmol/L.
Percentage of Participants With Hypercholesterolemia Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98) Hypercholesterolemia was defined as cholesterol levels \>240 mg/dL or 6.2 mmol/L.
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.
- Secondary Outcome Measures
Name Time Method Calculated GFR Using the Nankivell Equation (mL/Min) Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min\]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine \[in millimoles per liter (mmol/L)\]) plus (0.25\*body weight \[in kilograms (kg)\]) minus (0.5\*serum urea \[mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea\]) minus (100 per height \[in meters\] square) plus (35 for male/25 for female). A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.
Reciprocal of Serum Creatinine Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Serum Triglyceride Levels by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98) EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and \>1000 copies/PCR.
Calculated GFR Using Cockcroft-Gault Equation (mL/Min) Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)\*(140 minus age in years) divided by (72\*serum creatinine \[mg/dL\]). For females value obtained was multiplied by 0.85. A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels ≥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose ≥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose ≥200 mg/dL during an OGTT (Oral Glucose Tolerance Test).
Low-Density Lipoprotein (LDL) Levels by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Ratio of Total Serum Cholesterol Level to HDL Level by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Percentage of Participants Requiring Anti-Hypertensive Medication by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Total Cholesterol Levels by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) High-Density Lipoprotein (HDL) Levels by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Ratio of Serum LDL Level to HDL Level by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit Months 12 and 24 Homeostatic Model Assessment (HOMA)-%B by Visit Months 12 and 24 HOMA-%B = (20 times \[\*\] fasting serum insulin) divided by (/) (fasting serum glucose minus \[-\] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements.
Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit Months 12 and 24 Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement.
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale Baseline, Months 12, 18, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement.
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98) Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included.
Fasting Serum Glucose Levels (mg/dL) by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale Months 12, 18, and 24 The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Percentage of Participants Requiring Lipid-Lowering Agents by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 BK Virus (BKV) DNA Levels Determined Using PCR by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.
Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit Months 12 and 24 Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.
AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit Months 12 and 24 The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.
Trough Levels of Tacrolimus (ng/mL) by Visit Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98) Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Calculated as number of copies per 500 mg DNA.
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist.
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss.
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for ≥6 consecutive weeks, or death.
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Hemoglobin A1c (HbA1c) Levels by Visit Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98) Tofacitinib Concentrations in Plasma (ng/mL) by Visit Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98) Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale Baseline, Months 12, 18, and 24 ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question "At the moment, how much do you suffer?" for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire Months 12, 18, and 24 HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'.
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN Months 12, 18, 24, 36, 48, 60, 72, 84, and 96 Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist.
HOMA Insulin Resistance (IR) by Visit Months 12 and 24 HOMA-IR=fasting serum insulin\*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement.
SF-36 v2 Subscale Scores by Visit Months 12, 18, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Change From Baseline in SF-36 v2 Subscale Scores by Visit Baseline, Months 12, 18, and 24 SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 "how would you rate your health in general now?" (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement.
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale Months 12, 18, and 24 ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question "At the moment, how much do you suffer?" for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction.
Trial Locations
- Locations (27)
Annette C & Harold C Simmons Transplant Institute
🇺🇸Dallas, Texas, United States
Transplant Research Institute
🇺🇸Los Angeles, California, United States
Balboa Institute of Transplantation
🇺🇸San Diego, California, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Northwestern University-Feinberg School of Medicine, Division of Organ Transplantation
🇺🇸Chicago, Illinois, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Legacy Good Samaritan Hospital
🇺🇸Portland, Oregon, United States
Northwest Renal Clinic
🇺🇸Portland, Oregon, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
Multi Organ Transplant Center
🇺🇸Los Angeles, California, United States
St. Vincent Medical Center
🇺🇸Los Angeles, California, United States
Stanford School of Medicine
🇺🇸Palo Alto, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
University of California, San Francisco, Kidney Transplant Unit
🇺🇸San Francisco, California, United States
University of Colorado Health Sciences Center Renal Clinical Trials Office
🇺🇸Aurora, Colorado, United States
University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Jack J Dreyfus Clinic
🇺🇸New York, New York, United States
New York Presbyterian Hospital / Weill Cornell Medical Center
🇺🇸New York, New York, United States
Recanati/Miller Transplantation Institute
🇺🇸New York, New York, United States
Legacy Transplant Services
🇺🇸Portland, Oregon, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Dallas Transplant Institute
🇺🇸Dallas, Texas, United States
Baylor All Saints Medical Center
🇺🇸Fort Worth, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States