- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00204191
Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
Open, Prospective, Randomized Study to Compare the Efficacy and Safety of Immunosuppression Regimens Based on Cyclosporine (Neoral®) and Tacrolimus (Prograf®) in Renal Transplant Patients
Study Overview
Detailed Description
Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center setting. Existing studies concentrated on benefits in safety and efficacy, but seldomly evaluated the cost-effectiveness of one treatment.
The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Zbigniew Wlodarczyk, MD, PhD
- Phone Number: +48 52 585 4044
- Email: kiktranspl@cm.umk.pl
Study Locations
-
-
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Bydgoszcz, Poland, 85-084
- Recruiting
- Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9
-
Principal Investigator:
- Zbigniew Wlodarczyk, MD
-
Sub-Investigator:
- Andrzej Adamowicz, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- First or second cadaveric kidney transplantation
- Age over 18 years old
- Specific indications or contraindications for cyclosporine or tacrolimus are absent
- Informed consent
Exclusion Criteria:
- Specific indications for use of cyclosporine or tacrolimus
- Specific contraindications for use of cyclosporine or tacrolimus
- Participation in another interventional clinical trial
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
graft survival
Time Frame: at one year
|
at one year
|
patient survival
Time Frame: at one year
|
at one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
renal function measured by serum creatinine (SCr)
Time Frame: at one year
|
at one year
|
lipid profile
Time Frame: throughout the study
|
throughout the study
|
total cost of the treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zbigniew Wlodarczyk, MD, PhD, Klinika Transplantologii, Collegium Medicum UMK Torun
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1/25/03
- IDS PL-02-RG-122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on tacrolimus
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Taro Pharmaceuticals USACompleted
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Peking Union Medical College HospitalUnknown
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Technical University of MunichCompleted
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Limerick BioPharmaCompleted
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