DiabetesMERFAPNCT01537445
MR-Evaluation of Renal Function-After-Pancreas-transplantation
An observational study of Diabetes and Renal Failure, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Diabetes, Renal Failure, Pancreas Transplantation
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with diabetes mellitus
Who may be able to join
- Patients with diabetes mellitus
- Patients undergoing a pancreas transplantation
Who cannot join
- Patients undergoing a pancreas transplantation and a renal transplantation at the same time.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University Hospital
Uppsala, Uppsala County, 75185
Per Liss, MD, PhD., +46186110000, per.liss@akademiska.se
About this study
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.
Read the 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.
- Conditions
- Diabetes, Renal Failure, Pancreas Transplantation
- Keywords
- Diabetes Mellitus, Pancreas, Renal failure, Transplantation
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pancreastransplantation | All patients undergoing pancreas transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney function
Improvements in kidney function (GFR) and proteinuria after pancreas transplantation.
Measured: Within 3 years
Secondary outcomes (1)
Kidney hemodynamics and oxygenation
Improvements in renal blood flow and kidney tissue oxygenation after pancreas transplantation.
Measured: Within 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Liss, Uppsala University
- Investigators
- Per Liss, MD, PhD., Study director, Uppsala University, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537445
- Sponsor's protocol ID
- MERFAP-2012
- Acronym
- MERFAP
- Status last verified
- Feb 2012
- First submitted
- 13 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-Evaluation of Renal Function-After-Pancreas-transplantation
- ClinicalTrials.gov ID
- NCT01537445
- Acronym / sponsor ID
- MERFAP / MERFAP-2012
- Conditions
- Diabetes, Renal Failure, Pancreas Transplantation
- Keywords
- Diabetes Mellitus, Pancreas, Renal failure, Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pancreastransplantation | – | –All patients undergoing pancreas transplantation. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes mellitus
Key inclusion criteria (2 listed)
- Patients with diabetes mellitus
- Patients undergoing a pancreas transplantation
Key exclusion criteria (1 listed)
- Patients undergoing a pancreas transplantation and a renal transplantation at the same time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kidney function
Time frame: Within 3 years
Improvements in kidney function (GFR) and proteinuria after pancreas transplantation.
1 secondary outcome
Kidney hemodynamics and oxygenation
Time frame: Within 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Liss, MD, PhD. study director
Uppsala University, Uppsala, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Renal Failure, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney function (time frame: Within 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2012.