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

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ClinicalTrials.gov Identifier: NCT02811835
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Stephan J.L. Bakker, University Medical Center Groningen

Study Description
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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.

Condition or disease
Transplantation Infection Renal Transplant Donor of Left Kidney

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1007 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
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
Actual Study Start Date : November 2008
Actual Primary Completion Date : May 2011
Estimated Study Completion Date : November 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Graft failure [ Time Frame: 20 years ]
    Return to dialysis or re-transplantation

  2. All-cause mortality [ Time Frame: 20 years ]
    Death


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
Serum and EDTA plasma stored at -80 degrees Centigrade Vials from 24h urine samples stored at -80 degrees Centigrade

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Renal Transplant Recipients and Healthy Potential Kidney Donors
Criteria

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

Exclusion Criteria: Acute illnesses, fever, current hospitalisation

-

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Stephan J.L. Bakker, Prof. dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02811835    
Other Study ID Numbers: METc2008/186
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Each participant has a study number which is not traceable to the patient in the study