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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Per Liss, Uppsala University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01537445
First Posted: February 23, 2012
Last Update Posted: February 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Per Liss, Uppsala University
  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:


Further study details as provided by Per Liss, Uppsala University:

Primary Outcome Measures:
  • Kidney function [ Time Frame: Within 3 years ]
    Improvements in kidney function (GFR) and proteinuria after pancreas transplantation.


Secondary Outcome Measures:
  • Kidney hemodynamics and oxygenation [ Time Frame: Within 3 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Per Liss, Associate professor, Uppsala University
ClinicalTrials.gov Identifier: NCT01537445     History of Changes
Other Study ID Numbers: MERFAP-2012
First Submitted: February 13, 2012
First Posted: February 23, 2012
Last Update Posted: February 23, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents


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