You are here

Study Evaluating Rapamune® Maintenance Regimen

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Deagu, , 700-712 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00478608
Pfizer
Completed
Study Evaluating Rapamune® Maintenance Regimen

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Study Evaluating Rapamune® Maintenance Regimen
Official Title  ICMJE 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
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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Renal Transplant
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
79
Original Enrollment  ICMJE
 (submitted: May 24, 2007)
70
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion DateNovember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00478608
Other Study ID Numbers  ICMJE 0468E-102362
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateApril 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now