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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT00895206
• Date of registration: 07/05/2009
• Prospective Registration: No
• Primary sponsor: University Hospital, Ghent
• Public title: Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study CD4-01
• Scientific title: Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
• Date of first enrolment: May 2009
• Target sample size: 128
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00895206
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Belgium

Contacts

• Name: Raymond Vanholder, MD, PhD
• Affiliation: University Hospital, Ghent

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Transplantation

Intervention(s)

Drug: golden standard therapy

Drug: individual adapted immunosuppression

Primary Outcome(s)

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

Secondary Outcome(s)

Development and evolution of glucose abnormalities [Time Frame: at 1 year]

Measured GFR [Time Frame: at month 3 and yearly]

CMV infection (as measured with whole blood PCR) and disease [Time Frame: at 1 year]

Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault) [Time Frame: at 1 year]

Incidence and score of chronic alloimmune injury/rejection and nonimmune injury [Time Frame: in month 3 and month 12 biopsies (BANFF 2005)]

Incidence of rejection treated by antibodies (OKT3, ATG) [Time Frame: at 1 year]

Time to first rejection (days) [Time Frame: at 1 year]

blood pressure [Time Frame: at 1 year]

Graft survival [Time Frame: at 1 year]

Incidence of BK nephritis [Time Frame: in month 3 and month 12 biopsies]

Number of acute rejections per patient [Time Frame: at 1 year]

Frequency of biopsy proven acute rejection episodes [Time Frame: at 1 year]

Incidence and score of borderline changes and acute rejection [Time Frame: in month 3 and month 12 biopsy]

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]

Fasting lipid profile [Time Frame: at baseline, month 1,3,6 and yearly]

Incidence of EBV reactivation (as measured with whole blood PCR) [Time Frame: at 1 year and yearly]

Incidence of PTLD and Nonmelanoma skin cancer [Time Frame: at 1 year and yearly]

Plasma creatinine and eGFR [Time Frame: at month 1, 3 and yearly (2 and 3 years)]

Left ventricular mass assessed by echocardiography [Time Frame: at 1 year and 3 years]

Polyoma virus replication as measured by whole blood PCR [Time Frame: at 1 year]

Proteinuria [Time Frame: at month 1, 3 and at 1 and 3 years]

ambulatory 24-hr blood pressure monitoring [Time Frame: at 1 year and 3 years]

Patient survival [Time Frame: at 1 year]

Severity of rejection as assessed by BANFF 2005 score [Time Frame: at 1 year]

Secondary ID(s)

2008/640

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG