Chronic Kidney DiseasePhase 2/3NCT00888290

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

A Phase 2/3 study testing Sodium bicarbonate in people with Chronic Kidney Disease, run by Albert Einstein College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Sodium bicarbonate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Mar 2009to May 2010
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Albert Einstein College of Medicine/ Montefiore Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

Read the 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.

Conditions: Chronic Kidney Disease
Being tested: Sodium bicarbonate, Placebos
Keywords: metabolic acidosis, chronic kidney disease, Estimated GFR 15-45
Medical subject headings: Renal Insufficiency, Chronic, Acidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium bicarbonateDrug
Also called sodium hydrogen carbonate
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
PlacebosDrug
Also called identical-appearing placebo
Placebo at 3 different doses to match Sodium bicarbonate dosing

Study groups in NCT00888290
Study group	Role	What they receive
Sodium Bicarbonate	Active comparator	Sequential design. Participants will be getting different doses of sodium bicarbonate during the study. Receives: Drug: Sodium bicarbonate
Placebos	Placebo comparator	Sequential design. Participants will be getting either placebo of different doses during the study. Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Bicarbonate Levels
Measured: 8 weeks

Secondary outcomes (2)

Muscle Strength as Measured by sit-to Stand Test
10 repetition sit-to-stand test
Measured: 8 weeks
Systolic Blood Pressure
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009May 2010

First posted27 Apr 2009 (estimated)
Study startMar 2009
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00888290
Sponsor's protocol ID: 2008-376
Status last verified: Aug 2022
First submitted: 23 Apr 2009
Last updated: 30 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 27495287
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.
PubMed 23393105

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects
ClinicalTrials.gov ID: NCT00888290
Acronym / sponsor ID: 2008-376
Conditions: Chronic Kidney Disease
Keywords: metabolic acidosis, chronic kidney disease, Estimated GFR 15-45
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Albert Einstein College of MedicineUniversity, hospital or other
Study start: Mar 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 27 Apr 2009 (estimated)
Results: Posted 30 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Sodium Bicarbonate	Active comparator	Drug: Sodium bicarbonateSequential design. Participants will be getting different doses of sodium bicarbonate during the study.
Placebos	Placebo comparator	Drug: PlacebosSequential design. Participants will be getting either placebo of different doses during the study.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium bicarbonateAlso: sodium hydrogen carbonateSodium 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	Drug	Sodium Bicarbonate
PlacebosAlso: identical-appearing placeboPlacebo at 3 different doses to match Sodium bicarbonate dosing	Drug	Placebos

Primary outcome

Serum Bicarbonate Levels
Time frame: 8 weeks

2 secondary outcomes

Muscle Strength as Measured by sit-to Stand Test
Time frame: 8 weeks
Systolic Blood Pressure
Time frame: 8 weeks

Results and safety

Results posted to the registry on 30 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	20	20

Primary outcome: Serum Bicarbonate Levels

Time frame: 8 weeks. Mean (Standard Deviation). Unit: mEq/L

Measure	Sodium Bicarbonate n = 20	Placebos n = 20
Value	25.5 (2.3)	22.2 (2.8)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sodium Bicarbonate	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Placebos	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27495287Chen 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 publication: PubMed 23393105Abramowitz 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.
Individual participant dataSharing planned: No

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Hostetter, MD principal investigator

Albert Einstein College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sodium bicarbonate in people with Chronic Kidney Disease, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Bicarbonate Levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00888290, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.