Clinical trial NCT00895206: Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
Official title: Individually Adapted Immunosuppression in de Novo Renal Transplantation Based on Immune Function Monitoring: a Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2009-05-08
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Graft function as measured by Cr EDTA AUC
timeFrame: at 1 year
Secondary outcomes:
measure: Graft survival
timeFrame: at 1 year
measure: Patient survival
timeFrame: at 1 year
measure: Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)
timeFrame: at 1 year
measure: Frequency of biopsy proven acute rejection episodes
timeFrame: at 1 year
measure: 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).
timeFrame: at 1 year
measure: Incidence of rejection treated by antibodies (OKT3, ATG)
timeFrame: at 1 year
measure: Time to first rejection (days)
timeFrame: at 1 year
measure: Severity of rejection as assessed by BANFF 2005 score
timeFrame: at 1 year
measure: Number of acute rejections per patient
timeFrame: at 1 year
measure: Plasma creatinine and eGFR
timeFrame: at month 1, 3 and yearly (2 and 3 years)
measure: Measured GFR
timeFrame: at month 3 and yearly
measure: Proteinuria
timeFrame: at month 1, 3 and at 1 and 3 years
measure: Incidence and score of borderline changes and acute rejection
timeFrame: in month 3 and month 12 biopsy
measure: Incidence and score of chronic alloimmune injury/rejection and nonimmune injury
timeFrame: in month 3 and month 12 biopsies (BANFF 2005)
measure: Development and evolution of glucose abnormalities
timeFrame: at 1 year
measure: blood pressure
timeFrame: at 1 year
measure: ambulatory 24-hr blood pressure monitoring
timeFrame: at 1 year and 3 years
measure: Left ventricular mass assessed by echocardiography
timeFrame: at 1 year and 3 years
measure: Fasting lipid profile
timeFrame: at baseline, month 1,3,6 and yearly
measure: CMV infection (as measured with whole blood PCR) and disease
timeFrame: at 1 year
measure: Polyoma virus replication as measured by whole blood PCR
timeFrame: at 1 year
measure: Incidence of BK nephritis
timeFrame: in month 3 and month 12 biopsies
measure: Incidence of PTLD and Nonmelanoma skin cancer
timeFrame: at 1 year and yearly
measure: Incidence of EBV reactivation (as measured with whole blood PCR)
timeFrame: at 1 year and yearly
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Raymond Vanholder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: