Alkali Therapy in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452412
• Other study ID #: 2009-408
• Secondary ID: R01DK087783
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2011
• Est. completion date: August 2016

Study information

• Verified date: December 2019
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Chronic Kidney Disease
• Kidney Diseases
• Metabolic Acidosis
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sodium bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
• Placebo
To be taken on the same schedule as the active arm

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	DEXA of Wrist	The investigators will evaluate changes in bone mineral density at the wrist.	2 year
Secondary	Hand-grip Strength	Hand-grip strength will be measured in all participants	2 year
Secondary	Estimated GFR	Estimated GFR	2 year
Secondary	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