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Alkali Therapy in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease, Metabolic Acidosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sodium bicarbonate
Placebo
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 Alkali, Sodium bicarbonate, Kidney disease, Acidosis

Eligibility Criteria

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

Inclusion Criteria:

  • Estimate GFR <= 45 and >15 ml/min/1.73m2
  • Age >18

Exclusion Criteria:

  • 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

Sites / Locations

  • Albert Einstein College of Medicine
  • Case Western Reserve University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sodium bicarbonate

Placebo

Arm Description

0.4 mEq/kg/day ideal body weight to be taken once a day

placebo dosage/frequency equivalent to sodium bicarbonate

Outcomes

Primary Outcome Measures

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.
DEXA of Wrist
The investigators will evaluate changes in bone mineral density at the wrist.

Secondary Outcome Measures

Hand-grip Strength
Hand-grip strength will be measured in all participants
Estimated GFR
Estimated GFR
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.

Full Information

First Posted
October 12, 2011
Last Updated
December 19, 2019
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01452412
Brief Title
Alkali Therapy in Chronic Kidney Disease
Official Title
Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Metabolic Acidosis
Keywords
Alkali, Sodium bicarbonate, Kidney disease, Acidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Description
0.4 mEq/kg/day ideal body weight to be taken once a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo dosage/frequency equivalent to sodium bicarbonate
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
0.4 mEq/kg/day ideal body weight to be taken once a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
To be taken on the same schedule as the active arm
Primary Outcome Measure Information:
Title
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times
Description
Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.
Time Frame
2 year
Title
DEXA of Wrist
Description
The investigators will evaluate changes in bone mineral density at the wrist.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Hand-grip Strength
Description
Hand-grip strength will be measured in all participants
Time Frame
2 year
Title
Estimated GFR
Description
Estimated GFR
Time Frame
2 year
Title
Quality of Life - Physical Function Domain
Description
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.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Estimate GFR <= 45 and >15 ml/min/1.73m2 Age >18 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hostetter, MD
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34784301
Citation
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.
Results Reference
derived
PubMed Identifier
31699517
Citation
Melamed 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.
Results Reference
derived

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Alkali Therapy in Chronic Kidney Disease

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