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Renal Tubular Acidosis in Incident Renal Transplant Recipients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283880
First Posted: January 26, 2011
Last Update Posted: May 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  Purpose
Metabolic acidosis is a common complication in incident renal transplant recipients. Protracted acidosis may be associated with osteoporosis, inflammation, negative protein balance and malnutrition, and last but not least may cause renal dysfunction. Preliminary data indicate an increased prevalence of nephrocalcinosis in renal transplant biopsies of incident patients presenting with metabolic acidosis. The present study aims (1)evaluate the prevalence and type of renal tubular acidosis (RTA) in incident renal transplant recipients and to identify clinical correlates and (2) to find associations between RTA, nephrolithiasis and nephrocalcinosis

Condition
Renal Transplant Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Renal Tubular Acidosis in Incident Renal Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
renal transplant recipients
Criteria

Inclusion Criteria:

  • Recipient of a single kidney transplant included in the protocol biopsy program.
  • eGFR > 30 ml/min
  • Age ≥ 18 years
  • Written informed consent

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283880


Contacts
Contact: Pieter Evenepoel, MD 003216344580 pieter.evenepoel@uz.kuleuven.ac.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Principal Investigator: Pieter Evenepoel, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Pieter Evenepoel, MD University Hospitals Leuven
  More Information

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01283880     History of Changes
Other Study ID Numbers: ML6919
First Submitted: January 25, 2011
First Posted: January 26, 2011
Last Update Posted: May 30, 2012
Last Verified: January 2011

Keywords provided by Universitaire Ziekenhuizen Leuven:
kidney
transplantation
metabolic acidosis
renal tubular acidosis
nephrocalcinosis

Additional relevant MeSH terms:
Acidosis
Acidosis, Renal Tubular
Acid-Base Imbalance
Metabolic Diseases
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn