Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

• 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: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Renal Insufficiency; Diabetes Mellitus	Drug: Sodium bicarbonate; Drug: Placebo	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Investigations of the Optimum Serum Bicarbonate Level in Renal Disease
• Actual Study Start Date: November 5, 2012
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sodium Bicarbonate; Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months	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: Placebo; Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.	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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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
3. 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.
4. 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
5. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Utah

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, United States, 84148

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Kalani L Raphael, MD; VA Salt Lake City Health Care System, Salt Lake City, UT

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] March 22, 2019

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01574157
• Other Study ID Numbers: CLIN-002-11F
• First Posted: April 10, 2012
• Results First Posted: August 28, 2019
• Last Update Posted: August 28, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases