Status:
COMPLETED
Metabolic Acidosis in Renal Transplant Patients
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
University of Texas Southwestern Medical Center
Swiss Federal Institute of Technology
Conditions:
Renal Transplant Patients
Metabolic Acidosis
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief Summary
Acidosis (accumulation of acid in the body) may be an underrecognized problem in patients after renal transplantation. It may have consequences on physical performance due to negative effects on bone ...
Detailed Description
Chronic kidney disease is developing to become one of the major health problems in the Western world with more than one million patients on renal replacement therapy, and many more expected in the yea...
Eligibility Criteria
Inclusion
- Patients with a renal graft having been transplanted within the previous 8 years and being at least 3 months post transplantation, or, patients scheduled to undergo transplantation from a living organ donor within the upcoming 3 months
- Venous serum bicarbonate concentration \< 24 mmol/L at time of baseline determination
- Renal transplant function with a calculated glomerular filtration rate (GFR) greater or equal 30 ml/min according to the Cockcroft-Gault formula
- Immunosuppressive therapy including a calcineurin inhibitor (cyclosporine A or tacrolimus)
- Age 20 through 65 years of either sex
- Written informed consent for study participation
Exclusion
- Acute rejection episode requiring specific therapy within 4 weeks before study inclusion
- Severe impairment in general health and/or physical handicaps (malignant neoplasia, catabolic state, acute systemic infection requiring therapy)
- Mental illness, psychiatric disorder
- Tetracycline intolerance
- Planned or "overt" pregnancy
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00913796
Start Date
December 1 2007
End Date
March 1 2010
Last Update
October 22 2010
Active Locations (1)
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1
University Hospital of Zurich
Zurich, Canton of Zurich, Switzerland, CH 8091