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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sodium bicarbonate
Placebos
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring metabolic acidosis, chronic kidney disease, Estimated GFR 15-45

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine/ Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sodium Bicarbonate

Placebos

Arm Description

Sequential design. Participants will be getting different doses of sodium bicarbonate during the study.

Sequential design. Participants will be getting either placebo of different doses during the study.

Outcomes

Primary Outcome Measures

Serum Bicarbonate Levels

Secondary Outcome Measures

Muscle Strength as Measured by sit-to Stand Test
10 repetition sit-to-stand test
Systolic Blood Pressure

Full Information

First Posted
April 23, 2009
Last Updated
August 12, 2022
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00888290
Brief Title
Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
Official Title
Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
metabolic acidosis, chronic kidney disease, Estimated GFR 15-45

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Bicarbonate
Arm Type
Active Comparator
Arm Description
Sequential design. Participants will be getting different doses of sodium bicarbonate during the study.
Arm Title
Placebos
Arm Type
Placebo Comparator
Arm Description
Sequential design. Participants will be getting either placebo of different doses during the study.
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Other Intervention Name(s)
sodium hydrogen carbonate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
identical-appearing placebo
Intervention Description
Placebo at 3 different doses to match Sodium bicarbonate dosing
Primary Outcome Measure Information:
Title
Serum Bicarbonate Levels
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Muscle Strength as Measured by sit-to Stand Test
Description
10 repetition sit-to-stand test
Time Frame
8 weeks
Title
Systolic Blood Pressure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hostetter, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine/ Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27495287
Citation
Chen W, Melamed ML, Hostetter TH, Bauer C, Raff AC, Almudevar AL, Lalonde A, Messing S, Abramowitz MK. Effect of oral sodium bicarbonate on fibroblast growth factor-23 in patients with chronic kidney disease: a pilot study. BMC Nephrol. 2016 Aug 5;17(1):114. doi: 10.1186/s12882-016-0331-6.
Results Reference
background
PubMed Identifier
23393105
Citation
Abramowitz MK, Melamed ML, Bauer C, Raff AC, Hostetter TH. Effects of oral sodium bicarbonate in patients with CKD. Clin J Am Soc Nephrol. 2013 May;8(5):714-20. doi: 10.2215/CJN.08340812. Epub 2013 Feb 7.
Results Reference
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Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

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