Metabolic Acidosis Clinical Trial
— MARTOfficial title:
Metabolic Acidosis and Its Impact on Mineral Metabolism and Physical Performance in Renal Transplant Patients
Verified date | June 2009 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich | Swiss Federal Institute of Technology, University of Texas Southwestern Medical Center |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correction of metabolic acidosis | 12 months | No | |
Secondary | Improvement in physical capacity | 12 months | No |
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