Chronic Kidney DiseasePhase 2/3NCT01452412
Alkali Therapy in Chronic Kidney Disease
A Phase 2/3 study testing Sodium bicarbonate in people with Chronic Kidney Disease and Metabolic Acidosis, run by Albert Einstein College of Medicine at 2 sites in United States.
Trial summary
Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Disease, Metabolic Acidosis
- What is being tested?
- Sodium bicarbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to Aug 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Estimate GFR <= 45 and >15 ml/min/1.73m2
- Age >18
Who cannot join
- Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
- bicarbonate level <20 or >25 mEq/L
- New York Heart Association Class III or IV heart failure
- Systolic blood pressure >180 mmHg
- Initiation of ESRD treatment planned within 6 months
- Kidney transplantation
- Treatment with immunosuppressives within the last 3 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Western Reserve University
Cleveland, Ohio, 44106
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease
Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.
- Conditions
- Chronic Kidney Disease, Metabolic Acidosis
- Being tested
- Sodium bicarbonate, Placebo
- Keywords
- Alkali, Sodium bicarbonate, Kidney disease, Acidosis
- Medical subject headings
- Renal Insufficiency, Chronic, Acidosis, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
0.4 mEq/kg/day ideal body weight to be taken once a day
PlaceboDrug
To be taken on the same schedule as the active arm
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Experimental | 0.4 mEq/kg/day ideal body weight to be taken once a day Receives: Drug: Sodium bicarbonate |
| Placebo | Placebo comparator | placebo dosage/frequency equivalent to sodium bicarbonate Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times
Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.
Measured: 2 year
DEXA of Wrist
The investigators will evaluate changes in bone mineral density at the wrist.
Measured: 2 year
Secondary outcomes (3)
Hand-grip Strength
Hand-grip strength will be measured in all participants
Measured: 2 year
Estimated GFR
Estimated GFR
Measured: 2 year
Quality of Life - Physical Function Domain
Short Form- 36 (SF-36) will be performed in all participants. We will evaluate effects on the Physical Function Domain. The Physical Function Domain is scored from 0 to 100 with higher scores meaning better physical functioning.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2016
- Study completionAug 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Michal L. Melamed, Albert Einstein College of Medicine
- Investigators
- Thomas Hostetter, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452412
- Sponsor's protocol ID
- 2009-408
- Other IDs
- R01DK087783
- Status last verified
- Dec 2019
- First submitted
- 12 Oct 2011
- Last updated
- 7 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
Publications
Brightwell CR, Kulkarni AS, Paredes W, Zhang K, Perkins JB, Gatlin KJ, Custodio M, Farooq H, Zaidi B, Pai R, Buttar RS, Tang Y, Melamed ML, Hostetter TH, Pessin JE, Hawkins M, Fry CS, Abramowitz MK. Muscle fibrosis and maladaptation occur progressively in CKD and are rescued by dialysis. JCI Insight. 2021 Dec 22;6(24):e150112. doi: 10.1172/jci.insight.150112.
PubMed 34784301Melamed ML, Horwitz EJ, Dobre MA, Abramowitz MK, Zhang L, Lo Y, Mitch WE, Hostetter TH. Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial. Am J Kidney Dis. 2020 Feb;75(2):225-234. doi: 10.1053/j.ajkd.2019.07.016. Epub 2019 Nov 5.
PubMed 31699517
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01452412
- Acronym / sponsor ID
- 2009-408
- Conditions
- Chronic Kidney Disease, Metabolic Acidosis
- Keywords
- Alkali, Sodium bicarbonate, Kidney disease, Acidosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
- Study start
- Oct 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Posted 7 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Experimental | Drug: Sodium bicarbonate0.4 mEq/kg/day ideal body weight to be taken once a day |
| Placebo | Placebo comparator | Drug: Placeboplacebo dosage/frequency equivalent to sodium bicarbonate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Estimate GFR <= 45 and >15 ml/min/1.73m2
- Age >18
Key exclusion criteria (7 listed)
- Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
- bicarbonate level <20 or >25 mEq/L
- New York Heart Association Class III or IV heart failure
- Systolic blood pressure >180 mmHg
- Initiation of ESRD treatment planned within 6 months
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 bicarbonate0.4 mEq/kg/day ideal body weight to be taken once a day | Drug | Sodium bicarbonate |
| PlaceboTo be taken on the same schedule as the active arm | Drug | Placebo |
Primary outcome
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times
Time frame: 2 year
Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.
DEXA of Wrist
Time frame: 2 year
The investigators will evaluate changes in bone mineral density at the wrist.
3 secondary outcomes
Hand-grip Strength
Time frame: 2 year
Estimated GFR
Time frame: 2 year
Quality of Life - Physical Function Domain
Time frame: 2 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34784301Brightwell CR, Kulkarni AS, Paredes W, Zhang K, Perkins JB, Gatlin KJ, Custodio M, Farooq H, Zaidi B, Pai R, Buttar RS, Tang Y, Melamed ML, Hostetter TH, Pessin JE, Hawkins M, Fry CS, Abramowitz MK. Muscle fibrosis and maladaptation occur progressively in CKD and are rescued by dialysis. JCI Insight. 2021 Dec 22;6(24):e150112. doi: 10.1172/jci.insight.150112.
- Derived from this study: PubMed 31699517Melamed ML, Horwitz EJ, Dobre MA, Abramowitz MK, Zhang L, Lo Y, Mitch WE, Hostetter TH. Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial. Am J Kidney Dis. 2020 Feb;75(2):225-234. doi: 10.1053/j.ajkd.2019.07.016. Epub 2019 Nov 5.
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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
Case Western Reserve University
2 sites 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 and Metabolic Acidosis, run by Albert Einstein College of Medicine at 2 sites 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 7 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 7 Jan 2020). 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?
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times (time frame: 2 year). The study lists 2 primary outcomes in all. 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 NCT01452412, 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 7 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.