Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01574157
First received: March 27, 2012
Last updated: July 17, 2014
Last verified: July 2014

March 27, 2012
July 17, 2014
November 2012
July 2016   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Urinary TGF-b1 is considered a marker of renal fibrosis
Same as current
Complete list of historical versions of study NCT01574157 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
These are biomarkers of renal complement system activation
Same as current
Not Provided
Not Provided
 
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Chronic Renal Insufficiency
  • Diabetes Mellitus
  • 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.
  • Active Comparator: Arm 1
    Sodium bicarbonate
    Intervention: Drug: Sodium bicarbonate
  • Placebo Comparator: Arm 2
    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
74
July 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Veteran
  • Age older than 18 years
  • Type II 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 eGFR 15 - 89 ml/min/1.73m2 using the CKD-EPI 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

Both
18 Years and older
No
Contact: Kalani L Raphael, MD (801) 582-1565 ext 1234 Kalani.Raphael@va.gov
United States
 
NCT01574157
CLIN-002-11F
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Kalani L. Raphael, MD VA Salt Lake City Health Care System, Salt Lake City, UT
Department of Veterans Affairs
July 2014

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