Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Department of Veterans Affairs
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: March 27, 2012
Last updated: February 6, 2015
Last verified: February 2015

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.

Condition Intervention
Chronic Renal Insufficiency
Diabetes Mellitus
Drug: Sodium bicarbonate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Investigations of the Optimum Serum Bicarbonate Level in Renal Disease

Resource links provided by NLM:

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 74
Study Start Date: November 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Sodium bicarbonate
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.
Placebo Comparator: Arm 2
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.

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01574157

Contact: Kalani L Raphael, MD (801) 582-1565 ext 1234

United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Kalani L Raphael, MD    801-582-1565 ext 1234   
Principal Investigator: Kalani L. Raphael, MD         
Sponsors and Collaborators
Principal Investigator: Kalani L. Raphael, MD VA Salt Lake City Health Care System, Salt Lake City, UT
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs Identifier: NCT01574157     History of Changes
Other Study ID Numbers: CLIN-002-11F
Study First Received: March 27, 2012
Last Updated: February 6, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases processed this record on March 03, 2015