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Study of Sodium Bicarbonate in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01225796
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
Kalani Raphael, University of Utah

Brief Summary:
The purpose of this study is to compare the effect of sodium bicarbonate versus no sodium bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1 (TGF-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate levels (20 - 28 mmol/L).

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Sodium bicarbonate Early Phase 1

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. TGF-beta1 levels seem to be an important predictor of chronic allograft nephropathy, and alkalinizing agents may have an effect on TFG-beta1 excretion.

Retrospective analysis of participants in the African American Study of Kidney Disease and Hypertension showed the lowest risk of CKD progression was among those having baseline serum bicarbonate levels in the range of 28-30 mmol/L. Recent studies in people with pre-transplant CKD have suggested that increasing low serum bicarbonate levels (< 22 mmol/L) with alkalinizing agents such as sodium bicarbonate and sodium citrate may reduce CKD progression.

Design: this is an open-label randomized study testing the effect of a six-month intervention with sodium bicarbonate 650 mg orally thrice daily versus no sodium bicarbonate treatment on renal ammonia excretion and urinary TGF-beta1.

Visits will occur at baseline, 3 months, and 6 months. At each follow-up visit, the study coordinator or principal investigator will review a medical questionnaire with the participant and collect a sample of blood and urine for analysis of urinary TGF-beta1, metabolic panel, pH, urinary net acid excretion, urinary bicarbonate and urinary ammonia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Randomized Trial of Sodium Bicarbonate in Renal Transplant Recipients With Low-normal Serum Bicarbonate Levels
Study Start Date : November 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Urinary transforming growth factor-beta1 [ Time Frame: 6 months ]
    This is considered a surrogate marker of chronic allograft nephropathy (tubulointerstitial fibrosis).

Secondary Outcome Measures :
  1. urinary ammonia excretion [ Time Frame: 6 months ]
    a component of urinary acid excretion

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01225796

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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
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Principal Investigator: Kalani L Raphael, MD University of Utah

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Responsible Party: Kalani Raphael, Principal Investigator, University of Utah Identifier: NCT01225796    
Other Study ID Numbers: 00044216
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by Kalani Raphael, University of Utah:
Chronic allograft nephropathy
Urinary TGF-beta
Urinary acid excretion