Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02811835

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Acute illnesses, fever, current hospitalisation

-

Treatment and study plan

Primary outcomes

  1. Graft failure

    Time frame: 20 years

    Return to dialysis or re-transplantation

  2. All-cause mortality

    Time frame: 20 years

    Death

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: 20 years

    Cause specific mortality

  2. Cancer mortality

    Time frame: 20 years

    Cause specific mortality

  3. Infectious disease mortality

    Time frame: 20 years

    Cause specific mortality

Other outcomes

  1. Change in renal function

    Time frame: 20 years

    Change in renal function over time

  2. New Onset Diabetes After Transplantation

    Time frame: 20 years

    New Onset Diabetes

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: TxL-FN

Important dates

Study start
2008
Primary completion
2011
Study completion
2028
First posted
Jun 23, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.