Overview

This trial is active, not recruiting.

Conditions transplantation, kidney transplantation, immunosuppression
Treatment sirolimus, cyclosporine, tacrolimus
Phase phase 4
Sponsor National Taiwan University Hospital
Start date September 2002
Trial size 40 participants
Trial identifier NCT00166842, 910506, NTUH S92

Summary

The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Pharmacokinetics of sirolimus tablets in different regimens in de novo renal transplant patients
time frame:
Effect of dosage form conversion on sirolimus concentration in stable renal transplant patients.
time frame:

Secondary Outcomes

Measure
Effectiveness of different sirolimus dose regimens in rejection prevention
time frame:

Eligibility Criteria

Male or female participants from 13 years up to 65 years old.

Inclusion Criteria: - ages of 18 and 65, renal transplant patients Exclusion Criteria: - pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis before transplantation

Additional Information

Official title Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.
Description Sirolimus tablets will be available more than one year after the launch of sirolimus solution. Most patients on sirolimus solution will use sirolimus tablet instead. The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.