Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: individual adapted immunosuppression; Drug: golden standard therapy

• Registration Number: NCT00895206
• Lead Sponsor: University Hospital, Ghent

Brief Summary

This study is an open, randomised trial in which one group of patients (control) will receive the golden standard therapy and the other group (treatment) will receive individually adapted immunosuppression.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Primary Completion: 2016-08
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• First or second kidney transplantation
• Males and females, 18 years old or older
• Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/mL
• Patients must be capable of understanding the purpose and risks of the study and must sign an informed consent form

Exclusion Criteria

• Multiple organ transplantation (eg. kidney-pancreas, kidney-heart, kidney-liver,...)
• Transplantation of a patient who received another organ transplant previously except one kidney transplant
• Recipients of HLA-identical living-related renal transplants
• Patients with PRA > 10%, patients who have lost a first graft from rejection.
• Pregnant or lactating women
• WBC =< 2.5 x 109/L (IU), platelet count =< 100 x 109/L (IU), or Hb =< 6g/dl at the time of entry into the study
• Active peptic ulcer
• Severe diarrhea or other gastrointestinal disorders which might interfere with the ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
• Known HIV-1 or HTLV-1 positive tests
• History of malignancy in the past 5 years (with the exception of adequately treated basal or squamous skin cell carcinoma)
• The use of investigational drugs or other immunosuppressive drugs as those specified in this protocol
• Patients receiving bile acid sequestrants
• Psychological illness or condition interfering with the patient's compliance or ability to understand the requirements of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	individual adapted immunosuppression	individual adapted immunosuppression
2	golden standard therapy	golden standard therapy

Primary Outcome Measures

Name	Time	Method
Graft function as measured by Cr EDTA AUC	at 1 year

Secondary Outcome Measures

Name	Time	Method
Development and evolution of glucose abnormalities	at 1 year
Left ventricular mass assessed by echocardiography	at 1 year and 3 years
Fasting lipid profile	at baseline, month 1,3,6 and yearly
CMV infection (as measured with whole blood PCR) and disease	at 1 year
Polyoma virus replication as measured by whole blood PCR	at 1 year
Incidence of BK nephritis	in month 3 and month 12 biopsies
Incidence of PTLD and Nonmelanoma skin cancer	at 1 year and yearly
Incidence of EBV reactivation (as measured with whole blood PCR)	at 1 year and yearly
blood pressure	at 1 year
ambulatory 24-hr blood pressure monitoring	at 1 year and 3 years
Graft survival	at 1 year
Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)	at 1 year
Frequency of biopsy proven acute rejection episodes	at 1 year
Incidence of biopsy proven acute rejection (BPAR) and clinical (non-biopsy proven) acute rejection episodes treated by a full course anti-rejection therapy (e.g. steroids) (Treatment of rejection according to center practice).	at 1 year
Time to first rejection (days)	at 1 year
Severity of rejection as assessed by BANFF 2005 score	at 1 year
Number of acute rejections per patient	at 1 year
Plasma creatinine and eGFR	at month 1, 3 and yearly (2 and 3 years)
Measured GFR	at month 3 and yearly
Proteinuria	at month 1, 3 and at 1 and 3 years
Incidence and score of borderline changes and acute rejection	in month 3 and month 12 biopsy
Incidence and score of chronic alloimmune injury/rejection and nonimmune injury	in month 3 and month 12 biopsies (BANFF 2005)
Patient survival	at 1 year
Incidence of rejection treated by antibodies (OKT3, ATG)	at 1 year

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium