Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation (ISINODAT)
|ClinicalTrials.gov Identifier: NCT01268995|
Recruitment Status : Terminated (It was impossible to recruit the scheduled number of patients)
First Posted : January 4, 2011
Last Update Posted : January 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|New Onset Diabetes Mellitus After Renal Transplantation||Drug: Cyclosporine A Drug: Tacrolimus||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Prospective Trial to Evaluate the Effect of Conversion From Tacrolimus to Cyclosporine A After Early Initiation of Insulin Therapy in Patients With New-onset Diabetes Mellitus After Kidney Transplantation|
|Study Start Date :||September 2009|
|Actual Study Completion Date :||December 2010|
Experimental: Cyclosporine A
Patients in this arm will be switched from immunosuppressive therapy with Tacrolimus to Cyclosporine A. Furthermore, patients in this arm will commence insulin treatment with NPH-insulin to reach normoglycemia. After the achievement of normoglycemia the insulin treatment will be continued for three more weeks and than terminated.
Drug: Cyclosporine A
Patients randomized into arm A will be switched from Tacrolimus to Cyclosporine A. Conversion will be done by a "stop and go" protocol. Patients will take their last dose Tacrolimus in the morning of the day of conversion and will start taking Cyclosporine A in the evening of the same day at a dose of 3mg/kg/d. The first measurement of Cyclosporine A trough levels will be performed 3 days after conversion and the dose will then be adjusted if necessary. Furthermore, treatment with NPH insulin once daily in the morning will be initiated.
Active Comparator: Tacrolimus
Patients in this arm will remain on their immunosuppressive therapy with Tacrolimus. Furthermore, patients in this arm will commence insulin treatment with NPH-insulin to reach normoglycemia. After the achievement of normoglycemia the insulin treatment will be continued for three more weeks and than terminated.
Patients in arm B will remain on their immunosuppressive therapy with Tacrolimus. Furthermore, treatment with NPH insulin once daily in the morning will be initiated.
- 90 days OGTT [ Time Frame: 90 days ]The primary endpoint will be the difference in the 2h glucose value obtained from an oral glucose tolerance test (OGTT) after 90 days compared to baseline.
- Beta cell function [ Time Frame: 90 and 180 days ]One secondary endpoint is the change in beta cell function after 90 days compared to baseline as determined by a frequent sampling oral glucose glucose tolerance test.
- Graft rejection [ Time Frame: whole study period ]The rate of episodes of acute allograft rejection will be compared between the two treatment arms.
- Hypoglycemia [ Time Frame: whole study period ]The rate of clinically relevant hypoglycemic episodes will be desribed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268995
|Medical University of Vienna/General Hospital|
|Vienna, Austria, A-1090|