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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204191

Enrollment

300

Registered

2005-09-20

Start date

2003-05-31

Completion date

2007-12-31

Last updated

2007-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

kidney transplantation, Immunosuppression, Cyclosporine, Tacrolimus

Brief 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.

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.

Interventions

DRUGtacrolimus

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
graft survival	at one year
patient survival	at one year

Secondary

Measure	Time frame
renal function measured by serum creatinine (SCr)	at one year
lipid profile	throughout the study
total cost of the treatment	—

Countries

Poland

Contacts

Primary ContactZbigniew Wlodarczyk, MD, PhD

kiktranspl@cm.umk.pl+48 52 585 4044

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026