Overview

Metabolic Acidosis in Renal Transplant Patients

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
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 and muscle metabolism. Therefore, the purpose of this study is 1. to determine the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis 2. to study the effect of substituting base equivalents (citrate) on acid/base status of renal transplant patients with acidosis 3. to compare the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis before and after substitution with citrate
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Zurich
Collaborators:
Swiss Federal Institute of Technology
University of Texas Southwestern Medical Center
Treatments:
Citric Acid
Potassium Citrate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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