Study Evaluating Rapamune® Maintenance Regimen

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00478608
First received: May 24, 2007
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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.

Condition Intervention Phase
Renal Transplant
Drug: Sirolimus (Rapamune®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation. [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
    The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).


Secondary Outcome Measures:
  • Glomerular Filtration Rate (GFR) (Nankivell Method) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using the Nankivell formula. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poorer kidney function. A GFR <15 is consistent with kidney failure.

  • Serum Creatinine [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]
    Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.

  • Patient and Graft Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient survival defined as patients living with or without a functioning graft. Graft survival defined as those patients who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.

  • Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: No ]
    The diagnosis of acute rejection required a kidney biopsy. Biopsies were assessed using the Banff criteria, standardized diagnostic categories based on histological assessments (e.g., cell types and distributions).


Enrollment: 79
Study Start Date: March 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sirolimus (Rapamune®)
    (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478608

Locations
Korea, Republic of
Deagu, Korea, Republic of, 700-721
Deagu, Korea, Republic of, 700-712
Pusan, Korea, Republic of, 614-735
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 110-744
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00478608     History of Changes
Other Study ID Numbers: 0468E-102362
Study First Received: May 24, 2007
Results First Received: November 30, 2009
Last Updated: April 22, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014