Alkali Therapy in Chronic Kidney Disease

Phase 2

Completed

• Conditions: Chronic Kidney Disease; Metabolic Acidosis
• Interventions: Drug: Placebo; Drug: Sodium bicarbonate

• Registration Number: NCT01452412
• Lead Sponsor: Albert Einstein College of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-12
• Study First Posted: 2011-10-14
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2019-11-13
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-19
• Last Update Submitted: 2019-12-19
• Results First Posted: 2020-01-07
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo dosage/frequency equivalent to sodium bicarbonate
Sodium bicarbonate	Sodium bicarbonate	0.4 mEq/kg/day ideal body weight to be taken once a day

Primary Outcome Measures

Name	Time	Method
DEXA of Wrist	2 year	The investigators will evaluate changes in bone mineral density at the wrist.
Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times	2 year	Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.

Secondary Outcome Measures

Name	Time	Method
Quality of Life - Physical Function Domain	2 year	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.
Estimated GFR	2 year	Estimated GFR
Hand-grip Strength	2 year	Hand-grip strength will be measured in all participants

Trial Locations

Locations (2)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States