Status:
COMPLETED
Studies of Organ Transplantation in Animals and Man
Lead Sponsor:
Michael Mauer, MD
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Brief Summary
A. To study the effects of pancreas transplantation (PT) on the structural abnormalities of diabetic nephropathy (DN) in patients with type 1 (insulin-dependent) diabetes mellitus (type 1 D). These st...
Detailed Description
These continuation studies focus on large pancreas (PTx) and kidney (KTx) transplant populations of type 1 diabetic (D) patients (pts) in order to better understand diabetic nephropathy (DN), the lead...
Eligibility Criteria
Inclusion
- Pancreas Transplantation. The patients considered for recruitment are those being evaluated for pancreas transplant alone or pancreas transplant after kidney transplantation in IDDM patients at the University of Minnesota (U of M). The consent forms have been approved by the Institutional Review Board at the University of Minnesota and the transplant coordinators responsible for interacting with patients have continuously utilized these consent forms in the recruitment process.
- Long-Term Post Kidney Transplant IDDM Patients. These patients are recruited by a study coordinator working directly with the PI and also use consent forms approved by the Institutional Review Board at the University of Minnesota.
Exclusion
- Pancreas Transplantation Alone
- Serum creatinine \>1.5 mg/dl or CCr \<50 ml/min/1.73M2, as kidneys in such IDDM patients are approaching end stage renal disease and are not readily amenable to morphometric analysis.
- Solitary kidneys or evidence of unilateral renal disease, based upon significant discrepancies in renal size by ultrasound.
- Evidence of other important kidney disease by history, ultrasound, or baseline biopsy.
- Other chronic diseases or conditions, in addition to IDDM, such as cystic fibrosis, serious mental illness, severe mental retardation, etc.
- Pregnancy. Pregnancy tests will be performed on all eligible females of child-bearing age, and pregnant women will be excluded. Patients will again be eligible 3 months after completion of pregnancy.
- Pancreas Transplantation After Kidney Transplantation
- Serum creatinine \>2 mg/dl; a higher value is accepted than for native kidney patients since patients have a single kidney and are receiving CSA or FK506.
- Moderate to severe chronic rejection on baseline biopsy.
- Evidence of other important kidney disease by history, ultrasound, or baseline biopsy.
- Other chronic diseases or conditions, in addition to IDDM, such as cystic fibrosis, serious mental illness, severe mental retardation, etc.
- Pregnancy. Pregnancy tests will be performed on all eligible females of child-bearing age, and pregnant women will be excluded. Patients will again be eligible 3 months after completion of pregnancy.
Key Trial Info
Start Date :
January 1 1981
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
655 Patients enrolled
Trial Details
Trial ID
NCT00156364
Start Date
January 1 1981
End Date
August 1 2014
Last Update
December 11 2014
Active Locations (1)
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1
Universtity of Minnesota, Department of Pediatric Nephrology
Minneapolis, Minnesota, United States, 55455