NCT00478608

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. 1.To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 25, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 7, 2010

Completed
Last Updated

April 28, 2010

Status Verified

April 1, 2010

Enrollment Period

1.7 years

First QC Date

May 24, 2007

Results QC Date

November 30, 2009

Last Update Submit

April 22, 2010

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.

    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).

    6 months after transplantation

Secondary Outcomes (4)

  • Glomerular Filtration Rate (GFR) (Nankivell Method)

    6 and 12 months

  • Serum Creatinine

    Baseline, 6 and 12 months

  • Patient and Graft Survival

    12 months

  • Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation

    12 months after transplantation

Interventions

Sirolimus (Rapamune®)DRUG

(1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 13 years of age.
  • 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.
  • Patients with a panel of reactive antibody (%PRA) less than or equal to 50%

You may not qualify if:

  • Evidence of active systemic or localized major infection at the time of initial sirolimus administration.
  • Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
  • Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
  • 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).
  • Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Deagu, 700-712, South Korea

Location

Unknown Facility

Deagu, 700-721, South Korea

Location

Unknown Facility

Pusan, 614-735, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Unknown Facility

Seoul, 137-701, South Korea

Location

Unknown Facility

Seoul, 138-736, South Korea

Location

Unknown Facility

Suwon, 443-721, South Korea

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
U. S. Contact Center
Organization
Wyeth
clintrialresults@wyeth.com

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 25, 2007

Study Start

March 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

April 28, 2010

Results First Posted

January 7, 2010

Record last verified: 2010-04

Locations

KR(9)