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Study of Sodium Bicarbonate in Kidney Transplant Recipients

This study is currently recruiting participants.
Verified June 2012 by University of Utah
Sponsor:
Information provided by (Responsible Party):
Kraphael, University of Utah
ClinicalTrials.gov Identifier:
NCT01225796
First received: October 15, 2010
Last updated: June 1, 2012
Last verified: June 2012
History of Changes
  Purpose

About half of transplanted kidneys continue to work ten years after the time of transplant. The purpose of this study is to test whether oral sodium bicarbonate might improve the long-term function of a transplanted kidney.


Condition Intervention
Kidney Transplantation
 Drug: Sodium bicarbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Sodium Bicarbonate in Renal Transplant Recipients With Low-normal Serum Bicarbonate Levels

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Urinary transforming growth factor-beta1 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This is considered a surrogate marker of chronic allograft nephropathy (tubulointerstitial fibrosis).


Secondary Outcome Measures:
  • urinary ammonia excretion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    a component of urinary acid excretion


Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium bicarbonate
This group will receive oral sodium bicarbonate 650mg three times daily for 6 months.
 Drug: Sodium bicarbonate
Sodium bicarbonate 650mg by mouth three times daily for 6 months.
No Intervention: Control
This group will not receive any sodium bicarbonate.

Detailed Description:

Renal allograft survival ten years after transplant is only about 50%. In people with non-transplant chronic kidney disease (CKD), sodium bicarbonate treatment seems to delay progressive decline in kidney function in those with low serum bicarbonate levels (metabolic acidosis). This may be because sodium bicarbonate reduces renal ammonia production and hence fibrosis. Observational evidence suggests that people with CKD and low-normal serum bicarbonate levels might also benefit from sodium bicarbonate treatment. The benefit of sodium bicarbonate treatment on long-term renal allograft survival is not known. The purpose of this study is to determine the effect of oral sodium bicarbonate on:

  • urinary transforming growth factor-beta1, a marker of renal fibrosis
  • urinary ammonia excretion.
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Renal transplant recipients
  • Age 21-75 years
  • Six months since the time of the most recent transplant
  • Serum bicarbonate 20-28mM on the two most recent serum measures with the last six months
  • Stable creatinine

Exclusion Criteria:

  • Systolic blood pressure > 140mmHg
  • Diastolic blood pressure > 90mmHg
  • Known ejection fraction <50%
  • Clinical diagnosis of heart failure
  • Use of >3 antihypertensive agents
  • > 1+ edema
  • Use of alkali in the preceding 3 months
  • History of noncompliance with clinic visits
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225796

Contacts
Contact: Kalani L Raphael, MD 801-581-4270 kalani.raphael@hsc.utah.edu
Contact: Jennifer Zitterkoph, RD 801-585-5215 jennifer.zitterkoph@hsc.utah.edu

Locations
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kalani L Raphael, MD     801-581-4270     kalani.raphael@hsc.utah.edu    
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Jennifer Zitterkoph         jennifer.zitterkoph@hsc.utah.edu    
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Kalani L Raphael, MD University of Utah
  More Information

Publications:

Responsible Party: Kraphael, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT01225796     History of Changes
Other Study ID Numbers: 00044216
Study First Received: October 15, 2010
Last Updated: June 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Bicarbonate
Chronic allograft nephropathy
Urinary TGF-beta
Urinary acid excretion

ClinicalTrials.gov processed this record on June 18, 2013