Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204191
Status:
UNKNOWN
Last Update Posted:
2007-10-19
First Post:
2005-09-12
Brief Title:
Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
Sponsor:
Uniwersytet Mikolaja Kopernika w Toruniu
Organization:
Uniwersytet Mikolaja Kopernika w Toruniu
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDS PL-02-RG-122 | None | None | None |