Pancreas Allotransplantation for Diabetic Nephropathy and Mild Chronic REnal fAilure Stage Study
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Current medical therapies are not able to prevent progression of established macroproteinuira
(i.e. diabetic nephropathy) to end-stage renal failure in type 1 (insulin dependent) diabetic
patients. In this setting, proteinuria is a major risk factor for mortality. Pancreas
transplantation, on the contrary, can revert diabetic nephropathy and thereby prevent
end-stage chronic renal failure, with theoretically lower risk of death as compared to
current medical therapies.The main objective of this study is to assess superiority of
isolated pancreas transplantation versus intensive exogenous insulin therapy in type 1
diabetic patients with overt diabetic nephropathy and mildly reduced renal function. The
primary endpoint is a composite efficacy/failure end-point including: patient mortality and
renal function impairment during 5 years in patients with badly controlled diabetes and
nephropathy resisting to up-to-date nephroprotective therapies.Main secondary objectives are
safety and efficacy of both regimens, including proteinuria and renal histology evaluation,
metabolic control and quality of life, acute and chronic extrarenal complications of
diabetes, pancreas survival and all risks related to the transplant procedure (anaesthesia,
surgery and immunosuppression side-effects) and to the intensive insulin therapy management.