MR-Evaluation of Renal Function-After-Pancreas-transplant... | NCT01537445

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

NCT01537445

Sponsor

Uppsala University

Status

Unknown status

Last Update Posted

Feb 23, 2012Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Diabetes
Renal Failure
Pancreas Transplantation

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Feb 2015Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

Feb 13, 2012

First Submission Date that Met QC Criteria

Feb 22, 2012

First Posted Date

Feb 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2012

Last Update Posted Date

Feb 23, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with pancreastransplantation		All patients undergoing pancreas transplantation.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with diabetes mellitus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Per Liss, MD, PhD.	Uppsala University, Uppsala, Sweden	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Uppsala	Uppsala County	75185	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided