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Study Evaluating Rapamune® Maintenance Regimen

Last updated on May 11, 2018

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

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Study Evaluating Rapamune® Maintenance Regimen
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

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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Renal Transplant
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.
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
November 2008
November 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00478608
0468E-102362
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the

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

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