A Study to Evaluate FK778 in Kidney Transplant Patients

Study Overview
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Brief Summary
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A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients

Official Title
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A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients

Conditions
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Kidney Transplantation, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney, Grafting, Kidney

Intervention / Treatment
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* Drug: FK778


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons). Patient has been fully informed. Exclusion Criteria: Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons. Patient has significant liver disease. Cold ischemia time of the donor kidney >28 hours. Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. Patient has previously received or is receiving an organ transplant other than kidney.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FK778|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy-proven acute rejection over the first 24 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year |  |  | 
| Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year |  |  | 
| Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year |  |  | 
| Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year |  |  | 
| Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year |  |  | 
| Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year |  |  | 
| Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation. |  |  | 
| Safety first 24 weeks: Patient survival |  |  | 
| Graft survival |  |  | 
| Incidence of adverse events |  |  | 
| Routine safety laboratory parameters |  |  | 
| Haemoglobin values at weeks two to six |  |  | 
| Leukocytes at weeks two to six |  |  | 
| Thrombocytes at weeks two to six |  |  | 
| Bilirubin at weeks two to six |  |  | 
| Incidence of CMV viraemia |  |  | 
| Incidence of Diarrhoea, Gastroenteritis and Gastritis |  |  | 
| Safety after 1 year:Incidence of adverse events |  |  | 
| Patient and graft survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Efficacy, Treatment Effectiveness, Anti-rejection therapy, Immunosuppression, Antirejection, Malononitrilamide