Pancreas Allotransplantation for Diabetic Nephropathy and Mild Chronic REnal fAilure Stage Study (PANCREAS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01067950
First received: February 11, 2010
Last updated: June 1, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Procedure: Isolated Pancreas Transplant
Drug: Intensive Insulin Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: International, Multicenter, Prospective, Randomized, Parallel Group, Open Label Protocol to Evaluate Safety and Efficacy of Isolated Pancreas Transplantation Compared to Intensive Insulin Therapy in Type 1 Diabetic Patients With Overt Diabetic Nephropathy and Mildly Reduced Renal Function

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • The 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objectives are to evaluate and to compare the safety and the efficacy of the two treatments (IPT versus IIT). [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: March 2010
Arms Assigned Interventions
Experimental: Isolated Pancreas Transplant Procedure: Isolated Pancreas Transplant
Active Comparator: Intensive Insulin Therapy Drug: Intensive Insulin Therapy

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will be enroled in this study if they meet all of the following criteria:

  • Type 1 diabetic patient aged between 25 and 55 years at the time of randomisation.
  • Fasting plasma C-peptide below 0.5 ng/ml.
  • Badly controlled diabetes despite an optimized insulin regimen consisting in continuous subcutaneous insulin infusion (via an insulin pump) or in multiple daily injections of insulin
  • Persistent 24-hour proteinuria above 300 mg/day (a mean from 3 samples) despite adapted anti-proteinuric therapy for at least 6 months.
  • Cystatin C and/or Cr51-EDTA and/or DMSA-Tc scintigraphy measured glomerular filtration rate from 60 to 90 ml/min.
  • No contraindication to pancreas transplant surgery
  • Woman of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during first year of the study.
  • Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent has been obtained).
  • Affiliated to national insurance.

Exclusion Criteria:

Patients will be excluded from participating if any of the following criteria apply:

  • Patient with any type 2 diabetes and/or fasting plasma C-peptide above 0.5 ng/ml.
  • Pregnant woman or breast-feeding mothers.
  • Woman of childbearing potential unwilling to maintain effective birth control during first year of the study
  • Second transplant recipient or recipient with a functional grafted organ.
  • Proteinuria below 300 mg/day (a mean from 3 samples).
  • Albuminemia less than 30 g/l.
  • Cystatin C and/or Cr51-EDTA and/or DMSA-Tc scintigraphy measured glomerular filtration rate lower than 60 ml/min or higher than 90 ml/min.
  • Presence of any documented non-diabetic systemic disease potentially affecting the kidney.
  • Known allergy, hypersensibility or intolerance to any known insulin, to any of the recommended immunosuppressive agents of the study (Thymoglobulin, anti-lymphocyte serum Fresenius, tacrolimus, cyclosporin, mycophenolate mofetil, mycophenolic acid, corticosteroids etc), mocrolides antibiotics, or to any compound or excipient of all these products.
  • Currently participating in another clinical trial and/or has taken an investigational drug within four weeks prior enrolment.
  • Diagnosis of new-onset malignancy during 5 years before enrolment.
  • Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
  • Patient affected by active B hepatitis (HBsAg positive, HBeAg positive or HBV-DNA positive) or by active C hepatitis (HCVAb positive; HCV-RNA positive).
  • Patient HIV positive.
  • Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
  • Obesity (body mass index above than 30 kg/m2).
  • Severe iliac vessel calcifications impeding surgery.
  • Advanced coronary artery disease
  • Left ventricular function less than 30%.
  • Plasma blood leukocytes less than 2,000 /mm3 or higher than 15,000/mm3
  • Plasma blood platelets less 60,000 /mm3 or higher than 500,000/mm3
  • Psychological disorders influencing drug compliance.
  • Unable, unwilling or unlikely to comply fully with the protocol or the visits scheduled.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067950

Contacts
Contact: Diego CANTAROVICH, MD, PhD +33(0)240087440 diego.cantarovich@chu-nantes.fr

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: David ER SUTHERLAND         
Brazil
Albert Einstein Jewish Hospital Not yet recruiting
Sao Paulo, Brazil
Contact: Marcelo PEROSA         
Czech Republic
Diabetes Center - Institute for Clinical and Experimental Medicine Not yet recruiting
Praha, Czech Republic
Contact: Frantisek SAUDEK         
France
Hôpital Edouard-Herriot - Hospices Civils de Lyon Recruiting
Lyon, France
Contact: Charles THIVOLET         
Centre Hospitalier et Universitaire de Nantes Recruiting
Nantes, France
Contact: Diego CANTAROVICH, MD, PhD         
Italy
Istituto Scientifico Ospedale San Raffaele Not yet recruiting
Milano, Italy
Contact: Antonio SECCHI         
Azienda Ospedaliero-Universitaria Pisana Not yet recruiting
Pisa, Italy
Contact: Ugo BOGGI         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Diego CANTAROVICH, MD, PhD Nantes University Hospital
  More Information

No publications provided

Responsible Party: General Director, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01067950     History of Changes
Other Study ID Numbers: BRD 09/5-J
Study First Received: February 11, 2010
Last Updated: June 1, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
isolated pancreas transplant
intensive insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetic Nephropathies
Kidney Diseases
Kidney Failure, Chronic
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Urologic Diseases
Diabetes Complications
Renal Insufficiency, Chronic
Renal Insufficiency
Insulin, Globin Zinc
Insulin
Pancreatin
Pancrelipase
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014