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:
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:


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
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 April 17, 2014