Overview

This trial is active, not recruiting.

Conditions transplantation infection, renal transplant donor of left kidney
Sponsor University Medical Center Groningen
Start date November 2008
End date May 2011
Trial size 1007 participants
Trial identifier NCT02811835, METc2008/186

Summary

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, we 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Renal Transplant Recipients that were more than 1 year post-transplantation
Healthy subjects being evaluated as potential living kidney donors

Primary Outcomes

Measure
Graft failure
time frame: 20 years
All-cause mortality
time frame: 20 years

Secondary Outcomes

Measure
Cardiovascular mortality
time frame: 20 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: More than one year after transplantation, prognosis > 1 year, stable outpatients situation - Exclusion Criteria: Acute illnesses, fever, current hospitalisation

Additional Information

Official 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
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, we 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 we wrote a project on around the specific topic of the relation between dietary acid load, ammoniagenesis and its potential influence on blood pressure. We used this project to build a biobank and cohort in which we can test additional hypotheses on the relation between diet, contaminants and development of graft failure and the occurrence of mortality. We also included 300 healthy controls to compare diet, contaminant exposure and biomarkers with the renal transplant recipients.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Medical Center Groningen.