Know Cancer

or
forgot password

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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Kidney Transplantation

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Graft function as measured by Cr EDTA AUC

Outcome Time Frame:

at 1 year

Safety Issue:

No

Principal Investigator

Raymond Vanholder, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Ghent

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

2008/640

NCT ID:

NCT00895206

Start Date:

May 2009

Completion Date:

July 2013

Related Keywords:

  • Kidney Transplantation

Name

Location