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Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michal L. Melamed, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT00888290
First received: April 23, 2009
Last updated: October 12, 2011
Last verified: October 2011
History of Changes
  Purpose

This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.


Condition Intervention Phase
Chronic Kidney Disease
 Drug: Sodium bicarbonate
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • serum bicarbonate levels [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • muscle strength as measured by sit-to stand test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: March 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
Crossover design. Participants will be getting either placebo or different doses of sodium bicarbonate during the study.
 Drug: Sodium bicarbonate
Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated GFR < 45 ml/min/1.73m2 and >15 ml/min/1.73 m2 determined by abbreviated 4 variable modification MDRD equation
  • Age >21

Exclusion Criteria:

  • Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
  • Bicarbonate level <20 or >25 mEq/L
  • Decompensated heart failure
  • Systolic blood pressure >160 mm/Hg
  • Moderate or greater lower extremity edema
  • Initiation of ESRD treatment planned within 6 months
  • Kidney transplantation
  • Treatment with immunosuppressives within the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888290

Locations
United States, New York
Albert Einstein College of Medicine/ Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Thomas Hostetter, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Michal L. Melamed, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT00888290     History of Changes
Other Study ID Numbers: CCI#2008-376
Study First Received: April 23, 2009
Last Updated: October 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
metabolic acidosis
chronic kidney disease
Estimated GFR 15-45

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013