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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02811835
Other study ID # METc2008/186
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 21, 2016
Last updated August 17, 2017
Start date November 2008
Est. completion date November 2028

Study information

Verified date August 2017
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1007
Est. completion date November 2028
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: More than one year after transplantation, prognosis > 1 year, stable outpatients situation -

Exclusion Criteria: Acute illnesses, fever, current hospitalisation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Outcome

Type Measure Description Time frame Safety issue
Other Change in renal function Change in renal function over time 20 years
Other New Onset Diabetes After Transplantation New Onset Diabetes 20 years
Primary Graft failure Return to dialysis or re-transplantation 20 years
Primary All-cause mortality Death 20 years
Secondary Cardiovascular mortality Cause specific mortality 20 years
Secondary Cancer mortality Cause specific mortality 20 years
Secondary Infectious disease mortality Cause specific mortality 20 years
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