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

October 12, 2011
October 12, 2011
October 2011
January 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Alkali Therapy in Chronic Kidney Disease
Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Metabolic Acidosis
  • Drug: Sodium bicarbonate
    0.4 mEq/kg/day ideal body weight to be taken once a day
  • Drug: Placebo
    To be taken on the same schedule as the active arm
  • Experimental: Sodium bicarbonate
    Intervention: Drug: Sodium bicarbonate
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Lisandra Ninonuevo 718-430-3301
United States
 
NCT01452412
CCI-2009-408, R01DK087783
Yes
Michal L. Melamed, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)
Principal Investigator: Thomas Hostetter, MD Case Western Reserve University
Albert Einstein College of Medicine of Yeshiva University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP