NCT00888290

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

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

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
12.3 years until next milestone

Results Posted

Study results publicly available

August 30, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

April 23, 2009

Results QC Date

June 22, 2020

Last Update Submit

August 12, 2022

Conditions

Chronic Kidney Disease

Keywords

metabolic acidosischronic kidney diseaseEstimated GFR 15-45

Outcome Measures

Primary Outcomes (1)

  • Serum Bicarbonate Levels

    8 weeks

Secondary Outcomes (2)

  • Muscle Strength as Measured by sit-to Stand Test

    8 weeks

  • Systolic Blood Pressure

    8 weeks

Study Arms (2)

Sodium Bicarbonate

ACTIVE COMPARATOR

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

Drug: Sodium bicarbonate

Placebos

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Sodium bicarbonateDRUG

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

Also known as: sodium hydrogen carbonate
Sodium Bicarbonate
PlacebosDRUG

Placebo at 3 different doses to match Sodium bicarbonate dosing

Also known as: identical-appearing placebo
Placebos

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine/ Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (2)

  • 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.

    PMID: 27495287BACKGROUND

  • 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.

    PMID: 23393105RESULT

MeSH Terms

Conditions

Renal Insufficiency, ChronicAcidosis

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Michal Melamed
Organization
Albert Einstein College of Medicine
michal.melamed@einsteinmed.org
718-430-2496

Study Officials

  • Thomas Hostetter, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 27, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 30, 2022

Results First Posted

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)