A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
- Conditions
- Chronic Kidney Disease (CKD)Secondary Hyperparathyroidism (SHPT)
- Interventions
- Registration Number
- NCT04064827
- Lead Sponsor
- AbbVie
- Brief Summary
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
- Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
- Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial Screening.
- For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
- For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
- Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
- Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.
- Participant has had a parathyroidectomy within 12 weeks prior to Screening.
- Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to more than > 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to Dosing.
- Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.
- Participant is unable to take oral medications.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants Receiving Paricalcitol Paricalcitol Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieve Positive Response During Dosing Period 1 Up to Week 12 Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Incidence of Hypercalcemia During Dosing Period 1 Up to Week 12 Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined Up to Week 24 Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1 Up to Week 12 Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) During Dosing Period 1 Up to Week 12 Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Percentage of Participants Who Achieve a Positive Response During Dosing Period 2 Week 12 through Week 24 Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2 Week 12 through Week 24 Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) During Dosing Period 2 Week 12 through Week 24 Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Incidence of Hypercalcemia During Dosing Period 2 Week 12 through Week 24 Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined Up to Week 24 Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined Up to Week 24 Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) During Dosing Periods 1 and 2 Combined Up to Week 24 Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Trial Locations
- Locations (15)
Augusta University Medical Center /ID# 252149
🇺🇸Augusta, Georgia, United States
Arkansas Children's Hospital /ID# 225417
🇺🇸Little Rock, Arkansas, United States
Stanford University /ID# 252150
🇺🇸Redwood City, California, United States
Children's National Medical Center /ID# 225991
🇺🇸Washington, District of Columbia, United States
Holtz Childrens Hospital, University of Miami /ID# 225636
🇺🇸Miami, Florida, United States
Nicklaus Children's Hospital /ID# 210517
🇺🇸Miami, Florida, United States
Emory University /ID# 140665
🇺🇸Atlanta, Georgia, United States
Boston Children's Hospital /ID# 162863
🇺🇸Boston, Massachusetts, United States
Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057
🇺🇸Charlotte, North Carolina, United States
Wake Forest University Health Services /ID# 266045
🇺🇸Winston-Salem, North Carolina, United States
Children's Hospital of Philadelphia - Main /ID# 213802
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center /ID# 210495
🇺🇸Dallas, Texas, United States
University of Utah /ID# 140669
🇺🇸Salt Lake City, Utah, United States
Seattle Children's Hospital /ID# 162861
🇺🇸Seattle, Washington, United States
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663
🇵🇷San Juan, Puerto Rico