Clinical trial NCT00478608: Study Evaluating Rapamune® Maintenance Regimen
Official title: A Clinical Study to Evaluate the Efficacy and Safety of Cyclosporine (CsA) and Sirolimus (SRL) Induction Followed by Cyclosporine Withdrawal in Korean Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 79
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 13 years of age.
2. End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
3. Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

Exclusion Criteria:

1. Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
2. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
3. Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
4. History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
5. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.

Primary outcomes:
measure: Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.
timeFrame: 6 months after transplantation
Secondary outcomes:
measure: Glomerular Filtration Rate (GFR) (Nankivell Method)
timeFrame: 6 and 12 months
measure: Serum Creatinine
timeFrame: Baseline, 6 and 12 months
measure: Patient and Graft Survival
timeFrame: 12 months
measure: Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation
timeFrame: 12 months after transplantation
Other outcomes:
Locations:
city: Deagu
country: Korea, Republic of
city: Deagu
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: