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Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02031770
Recruitment Status : Completed
First Posted : January 9, 2014
Results First Posted : September 22, 2020
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
Denver Health and Hospital Authority
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE January 7, 2014
First Posted Date  ICMJE January 9, 2014
Results First Submitted Date  ICMJE September 3, 2020
Results First Posted Date  ICMJE September 22, 2020
Last Update Posted Date September 22, 2020
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2016)
Change in Brachial Artery Flow Mediated Dilation (FMD) [ Time Frame: 6 weeks and 12 weeks ]
The primary endpoint is change in brachial artery FMD between treatment and control conditions. Each treatment period is 6 weeks in duration with a 2 week washout period in between. Outcome measures will be repeated at the beginning and end of each period.
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
Brachial artery flow mediated dilation (FMD) [ Time Frame: 14 weeks ]
The primary endpoint is change in brachial artery FMD between treatment and control conditions.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease
Official Title  ICMJE Effect of Treatment of Metabolic Acidosis on Vascular Function in Patients With Chronic Kidney Disease: A Pilot Study
Brief Summary Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic acidosis is a common complication of CKD resulting from an inability of the diseased kidney to excrete the daily dietary acid load and it is associated with all-cause mortality in patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not been evaluated. The investigators propose a prospective, randomized, controlled, open-label 14-week crossover pilot study examining the effect of treatment of metabolic acidosis with oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV with metabolic acidosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metabolic Acidosis
  • Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Sodium bicarbonate
    Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.
  • Other: Control
    subjects will receive no treatment
Study Arms  ICMJE
  • A: Treatment/Control
    Patients will start with sodium bicarbonate treatment then switch to control (no treatment)
    Interventions:
    • Drug: Sodium bicarbonate
    • Other: Control
  • B: Control/Treatment
    Patients will start with control (no treatment) then switch to sodium bicarbonate treatment
    Interventions:
    • Drug: Sodium bicarbonate
    • Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Age 40-70 years
  • CKD stage IV (eGFR 15-29 ml/min/1.73m2; stable renal function in the past 3 months)
  • Serum bicarbonate level of < 20 and ≥ 16 meq/L (at least 2 consecutive weekly measurements)
  • Body mass index < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
  • Ability to give informed consent
  • Stable anti-hypertensive, diabetic and lipid lowering regimen for at least one month prior to randomization

Exclusion Criteria:

  • Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
  • Uncontrolled hypertension
  • Expected to undergo living related kidney transplant in next 6 months
  • Expected to start dialysis in next 3 months
  • Overt congestive heart failure
  • Use of sevelamer
  • Use of calcium carbonate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02031770
Other Study ID Numbers  ICMJE 13-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Denver Health and Hospital Authority
Investigators  ICMJE
Principal Investigator: Jessica Kendrick, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date September 2020

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