Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study (CD4-01)

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: individual adapted immunosuppression; Drug: golden standard therapy

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; individual adapted immunosuppression	Drug: individual adapted immunosuppression; individual adapted immunosuppression
Active Comparator: 2; golden standard therapy	Drug: golden standard therapy; golden standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Graft function as measured by Cr EDTA AUC	at 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Graft survival	at 1 year
Patient 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
Incidence of rejection treated by antibodies (OKT3, ATG)	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)
Development and evolution of glucose abnormalities	at 1 year
blood pressure	at 1 year
ambulatory 24-hr blood pressure monitoring	at 1 year and 3 years
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Roche Pharma AG
• Investigators: Principal Investigator: Raymond Vanholder, MD, PhD, University Hospital, Ghent

Publications and helpful links

Helpful Links

• Website of the University Hospital Ghent

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 7, 2009
• First Submitted That Met QC Criteria: May 7, 2009
• First Posted (Estimate): May 8, 2009

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2008/640