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Alkali Therapy in Chronic Kidney Disease

This study is currently recruiting participants.
Verified October 2011 by Albert Einstein College of Medicine of Yeshiva University
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 of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01452412
First received: October 12, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Metabolic Acidosis
 Drug: Sodium bicarbonate
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • HOMA-IR [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fasting bloods will be drawn to calculate a HOMA-IR score.

  • Sit to stand to sit speed [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Sit to stand to sit x10 speed will be measured and compared between groups.

  • DEXA of wrist [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The investigators will evaluate changes in bone mineral density at the wrist.

  • Urinary NGAL and KIM-1 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The investigators will evaluate biomarkers of kidney tubular function.


Secondary Outcome Measures:
  • Glucose disposal rate by euglycemic hyperinsulinemic clamp [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    30 participants will undergo insulin clamp procedure to assess insulin sensitivity at baseline and 2 months

  • Hand-grip strength [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Hand-grip strength will be measured in all participants

  • Serum PTH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Parathyroid hormone levels will be assessed

  • Bone-specific alkaline phosphatase [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Bone-specific alkaline phosphatase will be assessed in all participants

  • Serum calcium [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum phosphate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Serum 1,25-dihydroxyvitamin D [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • serum creatinine [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • serum cystatin C [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • urinary albumin/ creatinine ratio [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • urinary cystatin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium bicarbonate Drug: Sodium bicarbonate
0.4 mEq/kg/day ideal body weight to be taken once a day
Placebo Comparator: Placebo Drug: Placebo
To be taken on the same schedule as the active arm

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452412

Contacts
Contact: Lisandra Ninonuevo 718-430-3301

Locations
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Lisandra Ninonuevo     718-430-3301        
Contact: Michal Melamed, MD            
Principal Investigator: Michal L Melamed, MD, MHS            
Sub-Investigator: Matthew Abramowitz, MD, MS            
United States, Ohio
Case Western Reserve University Not yet recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Thomas Hostetter, MD            
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Thomas Hostetter, MD Case Western Reserve University
  More Information

No publications provided

Responsible Party: Michal L. Melamed, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01452412     History of Changes
Other Study ID Numbers: CCI-2009-408, R01DK087783
Study First Received: October 12, 2011
Last Updated: October 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Alkali
Sodium bicarbonate
Kidney disease
Acidosis

Additional relevant MeSH terms:
Acidosis
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Acid-Base Imbalance
Metabolic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 22, 2013