Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00302497
Other study ID # CCHI621ACA07
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received March 10, 2006
Last updated April 11, 2007
Start date April 2007
Est. completion date April 2008

Study information

Verified date February 2006
Source McGill University Health Center
Contact Jean Tchervenkov, MD
Phone 514 934 1934
Email tchervenkov@bell.blackberry.net
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The long-term use of calcineurin inhibitors in the maintenance phase after kidney transplantation is associated with typical adverse effects, such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnormalities.

This 15 month study with a safety follow up is undertaken to evaluate the potential benefit of an alternative treatment strategy to the chronic use of CNI. It will establish, through a comparative design, the superior protection of kidney function provided by chronic usage of basiliximab over tacrolimus early post-transplantation using EDC kidneys.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- male or female patients aged 40 to 75 years with a viable graft

- patients who are recipients of a primary or secondary graft from a cadaveric expanded donor criteria

- patients who had no change of immunosuppressor two weeks prior to baseline

- patients who had no acute rejection four weeks prior to baseline

- patients who are willing and capable of giving written informed consent for study participation

- females of childbearing potential must have a negative serum pregnancy test within 7 days prior to baseline.Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility

- Patients who are HCV and HBV negative

Exclusion Criteria

- patients who have a calculated GFR (Nankivell formula) of less than 30mL/min at baseline

- Patients who are recipients of multiple organ transplants

- Patients who are recipients of dual kidney transplants

- Patients with panel reactive antibodies >50% at transplant

- Patients with a known hypersensitivity to tacrolimus,EC-MPS or basiliximab at baseline

- Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin

- Patients who are HIV positive at study entry

- Patients who have received a kidney from a HCV positive or HBV positive donor

- Patients with signs of active immune process on graft biopsy at baseline

- Patients with polyoma (BK or JC)

- Patients with operative or technical failure

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
basiliximab


Locations

Country Name City State
Canada MUHC Royal Victoria Hospital Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the annualised change in GFR (delta GFR) at three and twelve months after baseline.
Secondary To demonstrate that the efficacy of basiliximab compared to the efficacy of tacrolimus kis comparable in the prevention of acute cellular rejection at 3 and 12 months after baseline.
See also
  Status Clinical Trial Phase
Completed NCT04087720 - Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant Phase 4
Completed NCT03749356 - Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients Phase 4
Withdrawn NCT05811468 - Study Correlation Between Blood, Tissue Gene Expression, Donor Derived Cell Free DNA and Histopathology in Kidney Transplant Recipients
Completed NCT03527238 - Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine Phase 2
Completed NCT00498576 - Melatonin and Adiponectin in Hypertensive Kidney Transplant N/A
Completed NCT00642655 - Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation Phase 1/Phase 2
Completed NCT00374400 - The Paired Donation Consortium Paired Donation Program N/A
Completed NCT01710033 - A Study Of CP-690,550 In Stable Kidney Transplant Patients Phase 1
Completed NCT00205257 - Prediction of Acute Rejection in Renal Transplant Phase 1
Completed NCT02711826 - Treg Therapy in Subclinical Inflammation in Kidney Transplantation Phase 1/Phase 2
Withdrawn NCT03978494 - Study to Compare Pharmacokinetics of Tacrolimus Prolonged-release (PR) Capsules and Advagraf® PR Capsules in Stable Kidney Transplant Patients. Phase 1
Completed NCT03837522 - Trial to Define the Benefits and Harms of Deceased Donor Kidney Procurement Biopsies N/A
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT05029310 - Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients Phase 4
Completed NCT03644485 - Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients Phase 4
Active, not recruiting NCT02409901 - Effects of Personalized Physical Rehabilitation in Kidney Transplant Recipients N/A
Completed NCT01047410 - ACtive Care After Transplantation, the ACT Study N/A
Completed NCT00940940 - Safety and Immunogenicity of Zostavax Vaccine in Patients Undergoing Living Donor Kidney Transplantation Phase 4
Completed NCT00270712 - A Study of Factors That Affect Long-Term Kidney Transplant Function
Completed NCT00217126 - The Study of Long-term Deterioration of Kidney Transplants. Phase 4