Improving Secretion of Insulin in New Onset Diabetes After Renal Transplantation (ISINODAT)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268995
|Medical University of Vienna/General Hospital|
|Vienna, Austria, A-1090|