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Alkali Therapy
Alkali Therapy in Chronic Kidney Disease
Phase 2 & 3
Waitlist Available
Led By Thomas Hostetter, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 year
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
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.
Eligible Conditions
- Chronic Kidney Disease
- Acidosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
DEXA of Wrist
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times
Secondary study objectives
Estimated GFR
Hand-grip Strength
Quality of Life - Physical Function Domain
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium bicarbonateExperimental Treatment1 Intervention
0.4 mEq/kg/day ideal body weight to be taken once a day
Group II: PlaceboPlacebo Group1 Intervention
placebo dosage/frequency equivalent to sodium bicarbonate
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium bicarbonate
FDA approved
Find a Location
Who is running the clinical trial?
Albert Einstein College of MedicineLead Sponsor
296 Previous Clinical Trials
11,689,304 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,304 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,843 Previous Clinical Trials
8,173,084 Total Patients Enrolled
Thomas Hostetter, MDPrincipal InvestigatorCase Western Reserve University
1 Previous Clinical Trials
20 Total Patients Enrolled