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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: golden standard therapy

Drug: individual adapted immunosuppression

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00895206

2008/640

Details and patient eligibility

About

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.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.