Alkali Therapy in Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Metabolic Acidosis
• Intervention / Treatment: Drug: Sodium bicarbonate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium bicarbonate; 0.4 mEq/kg/day ideal body weight to be taken once a day	Drug: Sodium bicarbonate; 0.4 mEq/kg/day ideal body weight to be taken once a day
Placebo Comparator: Placebo; placebo dosage/frequency equivalent to sodium bicarbonate	Drug: Placebo; To be taken on the same schedule as the active arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 year
DEXA of Wrist	The investigators will evaluate changes in bone mineral density at the wrist.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand-grip Strength	Hand-grip strength will be measured in all participants	2 year
Estimated GFR	Estimated GFR	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.	2 year

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Thomas Hostetter, MD, Case Western Reserve University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: October 12, 2011
• First Posted (Estimate): October 14, 2011

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Kidney disease; Sodium bicarbonate; Acidosis; Alkali
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Acid-Base Imbalance; Kidney Diseases; Renal Insufficiency, Chronic; Acidosis
• Other Study ID Numbers: 2009-408; R01DK087783 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• product manufactured in and exported from the U.S.: Yes