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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895206
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : October 13, 2016
Roche Pharma AG
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: individual adapted immunosuppression Drug: golden standard therapy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
Study Start Date : May 2009
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Graft function as measured by Cr EDTA AUC [ Time Frame: at 1 year ]

Secondary Outcome Measures :
  1. Graft survival [ Time Frame: at 1 year ]
  2. Patient survival [ Time Frame: at 1 year ]
  3. Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault) [ Time Frame: at 1 year ]
  4. Frequency of biopsy proven acute rejection episodes [ Time Frame: at 1 year ]
  5. 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 ]
  6. Incidence of rejection treated by antibodies (OKT3, ATG) [ Time Frame: at 1 year ]
  7. Time to first rejection (days) [ Time Frame: at 1 year ]
  8. Severity of rejection as assessed by BANFF 2005 score [ Time Frame: at 1 year ]
  9. Number of acute rejections per patient [ Time Frame: at 1 year ]
  10. Plasma creatinine and eGFR [ Time Frame: at month 1, 3 and yearly (2 and 3 years) ]
  11. Measured GFR [ Time Frame: at month 3 and yearly ]
  12. Proteinuria [ Time Frame: at month 1, 3 and at 1 and 3 years ]
  13. Incidence and score of borderline changes and acute rejection [ Time Frame: in month 3 and month 12 biopsy ]
  14. Incidence and score of chronic alloimmune injury/rejection and nonimmune injury [ Time Frame: in month 3 and month 12 biopsies (BANFF 2005) ]
  15. Development and evolution of glucose abnormalities [ Time Frame: at 1 year ]
  16. blood pressure [ Time Frame: at 1 year ]
  17. ambulatory 24-hr blood pressure monitoring [ Time Frame: at 1 year and 3 years ]
  18. Left ventricular mass assessed by echocardiography [ Time Frame: at 1 year and 3 years ]
  19. Fasting lipid profile [ Time Frame: at baseline, month 1,3,6 and yearly ]
  20. CMV infection (as measured with whole blood PCR) and disease [ Time Frame: at 1 year ]
  21. Polyoma virus replication as measured by whole blood PCR [ Time Frame: at 1 year ]
  22. Incidence of BK nephritis [ Time Frame: in month 3 and month 12 biopsies ]
  23. Incidence of PTLD and Nonmelanoma skin cancer [ Time Frame: at 1 year and yearly ]
  24. Incidence of EBV reactivation (as measured with whole blood PCR) [ Time Frame: at 1 year and yearly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895206

University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Roche Pharma AG
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent Identifier: NCT00895206     History of Changes
Other Study ID Numbers: 2008/640
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016