NCT01537445

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

3 years

First QC Date

February 13, 2012

Last Update Submit

February 22, 2012

Conditions

DiabetesRenal FailurePancreas Transplantation

Keywords

Diabetes MellitusPancreasRenal failureTransplantation

Outcome Measures

Primary Outcomes (1)

  • Kidney function

    Improvements in kidney function (GFR) and proteinuria after pancreas transplantation.

    Within 3 years

Secondary Outcomes (1)

  • Kidney hemodynamics and oxygenation

    Within 3 years

Study Arms (1)

Patients with pancreastransplantation

All patients undergoing pancreas transplantation.

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diabetes mellitus

You may qualify if:

  • Patients with diabetes mellitus
  • Patients undergoing a pancreas transplantation

You may not qualify if:

  • Patients undergoing a pancreas transplantation and a renal transplantation at the same time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Uppsala, Uppsala County, 75185, Sweden

Location

MeSH Terms

Conditions

Diabetes MellitusRenal Insufficiency

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Per Liss, MD, PhD.

    Uppsala University, Uppsala, Sweden

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 23, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2015

Study Completion

August 1, 2015

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations

SE(1)