Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

NCT01574157 | Completed Results DMC

• 1 other identifier: CLIN-002-11F
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Insufficiency; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)

  Urinary TGF-b1 is considered a marker of renal fibrosis

  The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.

Secondary Outcomes (5)

• Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)

  The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.

• Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)

  The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.

• Change in Urinary Levels of Fibronectin

  The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.

• Change in Urinary Albumin Levels

  The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.

• Change in Estimated Glomerular Filtration (eGFR)

  The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.

Study Arms (2)

Sodium Bicarbonate

ACTIVE COMPARATOR

Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months

Drug: Sodium bicarbonate

Placebo

PLACEBO COMPARATOR

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

Interventions

Sodium bicarbonate DRUG

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.

Sodium Bicarbonate

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Currently participating in another interventional research study

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Salt Lake City, Utah, 84148, United States

Location

Related Publications (1)

• Gardner J, Tuttle K, Raphael KL. Influence of Medications Containing Acid Salts on Serum Bicarbonate in CKD. Kidney360. 2020 Mar 31;1(5):330-336. doi: 10.34067/KID.0000532019. eCollection 2020 May 28.

  PMID: 35369374 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Change in urinary levels of Bb and membrane attack complex (MAC) were initial secondary outcomes. However, we had difficulty measuring these. Many subjects could not complete the physical activity assessment, which was an initial secondary outcome.

Results Point of Contact

• Title: Dr. Kalani Raphael, Principal Investigator
• Organization: VA Salt Lake City Healthcare System

kalani.raphael@va.gov

801-582-1565

Study Officials

• Kalani L Raphael, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 10, 2012
• Study Start: November 5, 2012
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)