Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

Open, Prospective, Randomized Study to Compare the Efficacy and Safety of Immunosuppression Regimens Based on Cyclosporine (Neoral®) and Tacrolimus (Prograf®) in Renal Transplant Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00204191
• Other study ID #: 1/25/03
• Secondary ID: IDS PL-02-RG-122
• Status: Recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: October 18, 2007
• Start date: May 2003
• Est. completion date: December 2007

Study information

• Verified date: September 2005
• Source: Uniwersytet Mikolaja Kopernika w Toruniu
• Contact: Zbigniew Wlodarczyk, MD, PhD
• Phone: +48 52 585 4044
• Email: kiktranspl[@]cm.umk.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• tacrolimus

Locations

Country	Name	City	State
Poland	Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9	Bydgoszcz

Sponsors (2)

Lead Sponsor	Collaborator
Uniwersytet Mikolaja Kopernika w Toruniu	Astellas Pharma Inc

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	graft survival		at one year
Primary	patient survival		at one year
Secondary	renal function measured by serum creatinine (SCr)		at one year
Secondary	lipid profile		throughout the study
Secondary	total cost of the treatment