NCT01452412

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

October 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

January 7, 2020

Completed
Last Updated

January 7, 2020

Status Verified

December 1, 2019

Enrollment Period

4.8 years

First QC Date

October 12, 2011

Results QC Date

November 13, 2019

Last Update Submit

December 19, 2019

Conditions

Chronic Kidney DiseaseMetabolic Acidosis

Keywords

AlkaliSodium bicarbonateKidney diseaseAcidosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Hand-grip Strength

    2 year

  • Estimated GFR

    2 year

  • Quality of Life - Physical Function Domain

    2 year

Study Arms (2)

Sodium bicarbonate

EXPERIMENTAL

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

Drug: Sodium bicarbonate

Placebo

PLACEBO COMPARATOR

placebo dosage/frequency equivalent to sodium bicarbonate

Drug: Placebo

Interventions

Sodium bicarbonateDRUG

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

Sodium bicarbonate
PlaceboDRUG

To be taken on the same schedule as the active arm

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

  • 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.

    PMID: 34784301DERIVED

  • 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.

    PMID: 31699517DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicAcidosisKidney Diseases

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic 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, MD
Organization
Albert Einstein College of Medicine
michal.melamed@einstein.yu.edu
718-430-2496

Study Officials

  • Thomas Hostetter, MD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 14, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 7, 2020

Results First Posted

January 7, 2020

Record last verified: 2019-12

Locations

US(2)