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

February 22, 2012 updated by: Per Liss, Uppsala University
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetes mellitus

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with pancreastransplantation
All patients undergoing pancreas transplantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney function
Time Frame: Within 3 years
Improvements in kidney function (GFR) and proteinuria after pancreas transplantation.
Within 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney hemodynamics and oxygenation
Time Frame: Within 3 years
Improvements in renal blood flow and kidney tissue oxygenation after pancreas transplantation.
Within 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Study Director: Per Liss, MD, PhD., Uppsala University, Uppsala, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

February 13, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (ESTIMATE)

February 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MERFAP-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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