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

Active, not recruiting

• Conditions: Transplantation Infection; Renal Transplant Donor of Left Kidney

• Registration Number: NCT02811835
• Lead Sponsor: University Medical Center Groningen

Brief 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, 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.

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 Timeline

• Study Start: 2008-11
• Primary Completion: 2011-05
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-23
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1007

Inclusion Criteria

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

Exclusion Criteria

Acute illnesses, fever, current hospitalisation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Graft failure	20 years	Return to dialysis or re-transplantation
All-cause mortality	20 years	Death

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality	20 years	Cause specific mortality
Cancer mortality	20 years	Cause specific mortality
Infectious disease mortality	20 years	Cause specific mortality