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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
University of Minnesota
Minneapolis, Minnesota, United States
NOT_YET_RECRUITINGAlbert Einstein Jewish Hospital
São Paulo, Brazil
NOT_YET_RECRUITINGDiabetes Center - Institute for Clinical and Experimental Medicine
Prague, Czechia
NOT_YET_RECRUITINGHôpital Edouard-Herriot - Hospices Civils de Lyon
Lyon, France
RECRUITINGCentre Hospitalier et Universitaire de Nantes
Nantes, France
RECRUITINGIstituto Scientifico Ospedale San Raffaele
Milan, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero-Universitaria Pisana
Pisa, Italy
NOT_YET_RECRUITINGThe primary end-point is the 5-year evaluation of efficacy/failure rate, a composite end-point including: (i) patient mortality and (ii) renal function impairment
Time frame: 5 years
Secondary objectives are to evaluate and to compare the safety and the efficacy of the two treatments (IPT versus IIT).
Time frame: 5 years
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