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Alkali Therapy in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01452412
Recruitment Status : Completed
First Posted : October 14, 2011
Results First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Michal L. Melamed, 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Metabolic Acidosis Drug: Sodium bicarbonate Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease
Study Start Date : October 2011
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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




Primary Outcome Measures :
  1. Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times [ Time Frame: 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.

  2. DEXA of Wrist [ Time Frame: 2 year ]
    The investigators will evaluate changes in bone mineral density at the wrist.


Secondary Outcome Measures :
  1. Hand-grip Strength [ Time Frame: 2 year ]
    Hand-grip strength will be measured in all participants

  2. Estimated GFR [ Time Frame: 2 year ]
    Estimated GFR

  3. Quality of Life - Physical Function Domain [ Time Frame: 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452412


Locations
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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Thomas Hostetter, MD Case Western Reserve University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michal L. Melamed, Associate Professor, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01452412    
Other Study ID Numbers: 2009-408
R01DK087783 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2011    Key Record Dates
Results First Posted: January 7, 2020
Last Update Posted: January 7, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Michal L. Melamed, Albert Einstein College of Medicine:
Alkali
Sodium bicarbonate
Kidney disease
Acidosis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acidosis
Urologic Diseases
Renal Insufficiency
Acid-Base Imbalance
Metabolic Diseases