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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00895206
First received: May 7, 2009
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: individual adapted immunosuppression
Drug: golden standard therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Graft function as measured by Cr EDTA AUC [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft survival [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Patient survival [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault) [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Frequency of biopsy proven acute rejection episodes [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Incidence of rejection treated by antibodies (OKT3, ATG) [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Time to first rejection (days) [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Severity of rejection as assessed by BANFF 2005 score [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Number of acute rejections per patient [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Plasma creatinine and eGFR [ Time Frame: at month 1, 3 and yearly (2 and 3 years) ] [ Designated as safety issue: No ]
  • Measured GFR [ Time Frame: at month 3 and yearly ] [ Designated as safety issue: No ]
  • Proteinuria [ Time Frame: at month 1, 3 and at 1 and 3 years ] [ Designated as safety issue: No ]
  • Incidence and score of borderline changes and acute rejection [ Time Frame: in month 3 and month 12 biopsy ] [ Designated as safety issue: No ]
  • Incidence and score of chronic alloimmune injury/rejection and nonimmune injury [ Time Frame: in month 3 and month 12 biopsies (BANFF 2005) ] [ Designated as safety issue: No ]
  • Development and evolution of glucose abnormalities [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • blood pressure [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • ambulatory 24-hr blood pressure monitoring [ Time Frame: at 1 year and 3 years ] [ Designated as safety issue: Yes ]
  • Left ventricular mass assessed by echocardiography [ Time Frame: at 1 year and 3 years ] [ Designated as safety issue: Yes ]
  • Fasting lipid profile [ Time Frame: at baseline, month 1,3,6 and yearly ] [ Designated as safety issue: Yes ]
  • CMV infection (as measured with whole blood PCR) and disease [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • Polyoma virus replication as measured by whole blood PCR [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
  • Incidence of BK nephritis [ Time Frame: in month 3 and month 12 biopsies ] [ Designated as safety issue: Yes ]
  • Incidence of PTLD and Nonmelanoma skin cancer [ Time Frame: at 1 year and yearly ] [ Designated as safety issue: Yes ]
  • Incidence of EBV reactivation (as measured with whole blood PCR) [ Time Frame: at 1 year and yearly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: May 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895206

Contacts
Contact: Wim Terryn, MD + 32 9 332 45 22

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Wim Terryn, MD    +32 9 332 45 22      
Sponsors and Collaborators
University Hospital, Ghent
Roche Pharma AG
Investigators
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00895206     History of Changes
Other Study ID Numbers: 2008/640
Study First Received: May 7, 2009
Last Updated: January 31, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on August 20, 2014