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MR-Evaluation of Renal Function-After-Pancreas-transplantation (MERFAP)

This study is not yet open for participant recruitment.
Verified February 2012 by Uppsala University
Sponsor:
Information provided by (Responsible Party):
Per Liss, Uppsala University
ClinicalTrials.gov Identifier:
NCT01537445
First received: February 13, 2012
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the beneficial effect of pancreas transplantation for long term kidney function in patients undergoing single-pancreas transplantation.


Condition
Diabetes
Renal Failure
Pancreas Transplantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MR-Evaluation of Renal Function-After-Pancreas-transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Kidney function [ Time Frame: Within 3 years ] [ Designated as safety issue: No ]
    Improvements in kidney function (GFR) and proteinuria after pancreas transplantation.


Secondary Outcome Measures:
  • Kidney hemodynamics and oxygenation [ Time Frame: Within 3 years ] [ Designated as safety issue: No ]
    Improvements in renal blood flow and kidney tissue oxygenation after pancreas transplantation.


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with pancreastransplantation
All patients undergoing pancreas transplantation.

Detailed Description:

Renal failure in patients who have performed a pancreas transplantation is a hazard for the outcome for these patients. The beneficial effect of pancreas transplantation for renal function is not clear. It is of major importance to early find patients who develops a decrease in renal function and start treatment early and closely monitor these patients in order to avoid further deteriorating renal function. In order to achieve this, there is a need for a easy, fast and sensitive method to evaluate renal function. In this study the investigators plan to use the non-invasive MR to evaluate changes in renal function.

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with diabetes mellitus

Criteria

Inclusion Criteria:

  • Patients with diabetes mellitus
  • Patients undergoing a pancreas transplantation

Exclusion Criteria:

  • Patients undergoing a pancreas transplantation and a renal transplantation at the same time.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537445

Locations
Sweden
University Hospital Not yet recruiting
Uppsala, Sweden, 75185
Contact: Per Liss, MD, PhD.     +46186110000     per.liss@akademiska.se    
Sponsors and Collaborators
Uppsala University
Investigators
Study Director: Per Liss, MD, PhD. Uppsala University, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Per Liss, Associate professor, Uppsala University
ClinicalTrials.gov Identifier: NCT01537445     History of Changes
Other Study ID Numbers: MERFAP-2012
Study First Received: February 13, 2012
Last Updated: February 22, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
Diabetes Mellitus
Pancreas
Renal failure
Transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
 Urologic Diseases
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013