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NCT Number: NCT01452412

Alkali Therapy in Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Acid-Base Imbalance Acidosis Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Acidosis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Albert Einstein College of Medicine, The Bronx, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

Drug

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

Placebo

Drug

To be taken on the same schedule as the active arm

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2011
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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