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Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

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ClinicalTrials.gov Identifier: NCT01574157
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE April 10, 2012
Results First Submitted Date  ICMJE June 26, 2019
Results First Posted Date  ICMJE August 28, 2019
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE November 5, 2012
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1) [ Time Frame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups. ]
Urinary TGF-b1 is considered a marker of renal fibrosis
Original Primary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1) [ Time Frame: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value. ]
Urinary TGF-b1 is considered a marker of renal fibrosis
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1) [ Time Frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups. ]
    KIM-1 is a marker of of kidney injury.
  • Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL) [ Time Frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups. ]
    NGAL is a marker of kidney injury
  • Change in Urinary Levels of Fibronectin [ Time Frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups. ]
    Fibronectin is a marker of kidney injury.
  • Change in Urinary Albumin Levels [ Time Frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups. ]
    Urinary albumin is a marker of kidney damage
  • Change in Estimated Glomerular Filtration (eGFR) [ Time Frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups. ]
    eGFR is a measure of kidney function
Original Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2012)
Change in urinary Bb and membrane attack complex (MAC) [ Time Frame: The mean of the 3-month and 6-month urinary Bb and MAC measurements will be compared to the baseline values. ]
These are biomarkers of renal complement system activation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
Official Title  ICMJE Investigations of the Optimum Serum Bicarbonate Level in Renal Disease
Brief Summary The purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease.
Detailed Description Diabetic chronic kidney disease (CKD) is a common problem in Veterans and progresses to end-stage renal disease in many people. It is important to identify treatment strategies that will help prevent the progression of CKD to overt kidney failure. The purpose of this study is to see if sodium bicarbonate reduces urinary markers of kidney damage in Veterans with diabetic CKD and normal serum bicarbonate levels.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Renal Insufficiency
  • Diabetes Mellitus
Intervention  ICMJE
  • Drug: Sodium bicarbonate
    Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
  • Drug: Placebo
    Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
Study Arms  ICMJE
  • Active Comparator: Sodium Bicarbonate
    Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months
    Intervention: Drug: Sodium bicarbonate
  • Placebo Comparator: Placebo
    Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.
    Intervention: Drug: Placebo
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: April 5, 2012)
74
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date May 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Veteran
  • Age older than 18 years
  • Diabetes mellitus
  • Serum bicarbonate 22 - 28 mmol/L on the most recent measurement within the past six months
  • Stage 2, 3, or 4 CKD (defined as estimated glomerular filtration rate (eGFR) 15 - 89 ml/min/1.73m2 using the CKD-Epidemiology equation)
  • Urinary albumin:creatinine ratio > 30 mg/gm on the most recent sample within the past 12 months.

Exclusion Criteria:

  • Lean body weight > 100 kg
  • Use of oral medications typically prescribed to raise low serum bicarbonate levels (i.e. sodium bicarbonate, sodium citrate, potassium citrate).
  • Serum potassium < 3.5 meq/L at enrollment visit
  • Use of 5 or more antihypertensive agents, regardless of the indications of each agent
  • Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg at the enrollment or baseline visit
  • Diagnosis of congestive heart failure with current, active Class III or IV New York Heart Association symptoms.
  • Significant fluid overload such that it is unsafe in the opinion of the PI for the patient to participate in the trial
  • chronic gastrointestinal disorder or any other factors judged to be likely to limit adherence to interventions (i.e. alcoholism, a history of missing clinic visits)
  • Chronic immunosuppressive therapy for transplanted organs or other indications
  • Individuals who are currently a member of a vulnerable population (I.e. incarcerated, pregnant).

    11.Currently participating in another interventional research study

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT01574157
Other Study ID Numbers  ICMJE CLIN-002-11F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kalani L Raphael, MD VA Salt Lake City Health Care System, Salt Lake City, UT
PRS Account VA Office of Research and Development
Verification Date August 2019

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