MR-Evaluation of Renal Function-After-Pancreas-transplantation

Diabetes Clinical Trial

— MERFAP  

Official title:

MR-Evaluation of Renal Function-After-Pancreas-transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01537445
• Other study ID #: MERFAP-2012
• Status: Not yet recruiting
• Phase: N/A
• First received: February 13, 2012
• Last updated: February 22, 2012
• Start date: February 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2012
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Pancreas Transplantation
• Renal Failure
• Renal Insufficiency

Locations

Country	Name	City	State
Sweden	University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kidney function	Improvements in kidney function (GFR) and proteinuria after pancreas transplantation.	Within 3 years	No
Secondary	Kidney hemodynamics and oxygenation	Improvements in renal blood flow and kidney tissue oxygenation after pancreas transplantation.	Within 3 years	No