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

Transplantation Infection Clinical Trial

— TxL-FN  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02811835
• Other study ID #: METc2008/186
• 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
• 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

Related Conditions & MeSH terms

• Renal Transplant Donor of Left Kidney
• Transplantation Infection

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