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

NCT00895206 | Completed Phase 4

• 1 other identifier: 2008/640
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Graft function as measured by Cr EDTA AUC

  at 1 year

Secondary Outcomes (24)

• Graft survival

  at 1 year

• Patient survival

  at 1 year

• Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)

  at 1 year

• Frequency of biopsy proven acute rejection episodes

  at 1 year

• 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).

  at 1 year

Study Arms (2)

1

EXPERIMENTAL

individual adapted immunosuppression

Drug: individual adapted immunosuppression

2

ACTIVE COMPARATOR

golden standard therapy

Drug: golden standard therapy

Interventions

individual adapted immunosuppression DRUG

individual adapted immunosuppression

1

golden standard therapy DRUG

golden standard therapy

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Roche Pharma AG: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• website of the University Hospital Ghent

Study Officials

• Raymond Vanholder, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

BE (1)