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

Kidney Transplantation Clinical Trial

— CD4-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895206
• Other study ID #: 2008/640
• Status: Completed
• Phase: Phase 4
• First received: May 7, 2009
• Last updated: October 12, 2016
• Start date: May 2009
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• individual adapted immunosuppression
individual adapted immunosuppression
• golden standard therapy
golden standard therapy

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Roche Pharma AG

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft function as measured by Cr EDTA AUC		at 1 year	No
Secondary	Graft survival		at 1 year	No
Secondary	Patient survival		at 1 year	No
Secondary	Graft function measured by estimated GFR (eGFR) (MDRD and Cockroft-Gault)		at 1 year	No
Secondary	Frequency of biopsy proven acute rejection episodes		at 1 year	No
Secondary	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	No
Secondary	Incidence of rejection treated by antibodies (OKT3, ATG)		at 1 year	No
Secondary	Time to first rejection (days)		at 1 year	No
Secondary	Severity of rejection as assessed by BANFF 2005 score		at 1 year	No
Secondary	Number of acute rejections per patient		at 1 year	No
Secondary	Plasma creatinine and eGFR		at month 1, 3 and yearly (2 and 3 years)	No
Secondary	Measured GFR		at month 3 and yearly	No
Secondary	Proteinuria		at month 1, 3 and at 1 and 3 years	No
Secondary	Incidence and score of borderline changes and acute rejection		in month 3 and month 12 biopsy	No
Secondary	Incidence and score of chronic alloimmune injury/rejection and nonimmune injury		in month 3 and month 12 biopsies (BANFF 2005)	No
Secondary	Development and evolution of glucose abnormalities		at 1 year	Yes
Secondary	blood pressure		at 1 year	Yes
Secondary	ambulatory 24-hr blood pressure monitoring		at 1 year and 3 years	Yes
Secondary	Left ventricular mass assessed by echocardiography		at 1 year and 3 years	Yes
Secondary	Fasting lipid profile		at baseline, month 1,3,6 and yearly	Yes
Secondary	CMV infection (as measured with whole blood PCR) and disease		at 1 year	Yes
Secondary	Polyoma virus replication as measured by whole blood PCR		at 1 year	Yes
Secondary	Incidence of BK nephritis		in month 3 and month 12 biopsies	Yes
Secondary	Incidence of PTLD and Nonmelanoma skin cancer		at 1 year and yearly	Yes
Secondary	Incidence of EBV reactivation (as measured with whole blood PCR)		at 1 year and yearly	Yes

External Links

•   website of the University Hospital Ghent