TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN) (TxL-FN)

August 17, 2017 updated by: Stephan J.L. Bakker, University Medical Center Groningen

Renal Sensing of the Acidifying Effect of Sulphur-containing Amino Acids: Consequences for the Relation Between Protein Intake and Blood Pressure in Renal Transplant Recipients

Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results. This study is a biobank and cohort study which investigates this hypothesis.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that due to poor homeostatic capacity and necessary use of immunosuppressive and other drugs, renal transplant recipients are much more susceptible to poor dietary habits and exposure to potentially toxic contaminants than people of the general population, and that this contributes to accelerated function loss of the graft and excess risk of premature mortality, both contributing to poor long-term results.

To investigate one part of this overarching hypothesis, the investigators wrote a project on around the specific topic of the relation between dietary acid load, ammoniagenesis and its potential influence on blood pressure. The investigators used this project to build a biobank and cohort in which they can test additional hypotheses on the relation between diet, contaminants and development of graft failure and the occurrence of mortality.

The investigators also included 300 healthy controls to compare diet, contaminant exposure and biomarkers with the renal transplant recipients.

Study Type

Observational

Enrollment (Actual)

1007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal Transplant Recipients and Healthy Potential Kidney Donors

Description

Inclusion Criteria: More than one year after transplantation, prognosis > 1 year, stable outpatients situation -

Exclusion Criteria: Acute illnesses, fever, current hospitalisation

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Renal Transplant Recipients
Renal Transplant Recipients that were more than 1 year post-transplantation
Healthy Controls
Healthy subjects being evaluated as potential living kidney donors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft failure
Time Frame: 20 years
Return to dialysis or re-transplantation
20 years
All-cause mortality
Time Frame: 20 years
Death
20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 20 years
Cause specific mortality
20 years
Cancer mortality
Time Frame: 20 years
Cause specific mortality
20 years
Infectious disease mortality
Time Frame: 20 years
Cause specific mortality
20 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in renal function
Time Frame: 20 years
Change in renal function over time
20 years
New Onset Diabetes After Transplantation
Time Frame: 20 years
New Onset Diabetes
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2008

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ANTICIPATED)

November 1, 2028

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (ESTIMATE)

June 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • METc2008/186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Each participant has a study number which is not traceable to the patient in the study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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