Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Protocol Title: Randomized open label study comparing the metabolic control of first Kidney Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral as part of a ATG induction, prednisone free and blood monitored Cellcept immunosuppressive regimen.

PURPOSE This is a single center medical research study to analyze post-transplant kidney recipients with pre-existing type 2 diabetes managed according to the recommended American Diabetes Association (ADA) guidelines. Prograf (Tac) and Neoral (CSA) are the two main medications to prevent rejection after transplantation. However, they may contribute to poorer diabetes control. The purpose of the study is to compare the effects of Prograf and Neoral on the control of Diabetes after kidney transplantation. In addition, all participants in this study will receive Thymoglobulin (anti-lymphocyte globulin) at the time of transplantation instead of long term prednisone (steroids).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Cyclosporine; Cyclosporins; Immunosuppressive Agents; Tacrolimus

Criteria

Inclusion Criteria:

Inclusion Criteria

1. Patient is a recipient of a first cadaveric kidney, or a kidney living donor mismatched (at least one mismatch.)

2. Patient is a minimum of 18 years of age at the time of transplant.

3. Patient has type 2 non-insulin dependent diabetes.

4. Patient or legal guardian has signed and dated an Ethics Committee-approved informed consent document and is willing and able to follow study procedures.

5. If female and is childbearing potential, patient has a negative pregnancy test and utilizes adequate contraceptive methods.

Exclusion Criteria

1. Recipients of a transplant graft from a donor age 65 and older.

2. Recipient of a multi-organ transplant.

3. Patients who are being re-transplanted will not be eligible for study.

4. Patients who have lost a previous graft to rejection less than one year from transplant.

5. Patient has any form of substance abuse, psychiatric disorder, or a condition in the opinion of the investigator, may invalidate communication with the investigator.

6. PRA > 30%