NCT00913796

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 and muscle metabolism. Therefore, the purpose of this study is

  1. 1.to determine the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis
  2. 2.to study the effect of substituting base equivalents (citrate) on acid/base status of renal transplant patients with acidosis
  3. 3.to compare the status of physical capacity and bone structure in renal transplant patients with metabolic acidosis before and after substitution with citrate

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 22, 2010

Status Verified

June 1, 2009

Enrollment Period

2.2 years

First QC Date

April 1, 2009

Last Update Submit

October 21, 2010

Conditions

Renal Transplant PatientsMetabolic AcidosisPhysical CapacityBone DiseaseMineral Metabolism

Keywords

Renal transplantationMetabolic acidosisPhysical capacityBone histologyBone histomorphometryParathyroid functionCalcium and phosphate metabolism

Outcome Measures

Primary Outcomes (1)

  • Correction of metabolic acidosis

    12 months

Secondary Outcomes (1)

  • Improvement in physical capacity

    12 months

Study Arms (2)

Postassium citrate

EXPERIMENTAL

Aim: correction of metabolic acidosis

Drug: Potassium citrate

Potassium chloride

ACTIVE COMPARATOR

Potassium chloride is given to compensate for any possible effects of potassium in potassium citrate (primary treatment).

Drug: Potassium chloride

Interventions

Potassium citrateDRUG

2.41 gram of citrate b.i.d. for 12 months. Dosage to be adjusted according to serum potassium concentration.

Postassium citrate
Potassium chlorideDRUG

370 mg potassium t.i.d. for 12 months. Dosage to be adjusted according to serum postassium concentration.

Potassium chloride

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, Canton of Zurich, CH 8091, Switzerland

Location

Related Publications (1)

  • Starke A, Corsenca A, Kohler T, Knubben J, Kraenzlin M, Uebelhart D, Wuthrich RP, von Rechenberg B, Muller R, Ambuhl PM. Correction of metabolic acidosis with potassium citrate in renal transplant patients and its effect on bone quality. Clin J Am Soc Nephrol. 2012 Sep;7(9):1461-72. doi: 10.2215/CJN.01100112. Epub 2012 Jul 5.

    PMID: 22773591DERIVED

MeSH Terms

Conditions

AcidosisBone Diseases

Interventions

Potassium CitratePotassium Chloride

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Citric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsPotassium Compounds

Study Officials

  • Patrice M. Ambühl, M.D.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2009

First Posted

June 4, 2009

Study Start

December 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 22, 2010

Record last verified: 2009-06

Locations

CH(1)