Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

NCT ID: NCT01574157

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-05
• Study Completion Date: 2018-05-01

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.

Conditions

Chronic Renal Insufficiency; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sodium Bicarbonate

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

Group Type: ACTIVE_COMPARATOR

Sodium bicarbonate

Intervention Type: 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.

Placebo

Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kalani L Raphael, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35369374 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLIN-002-11F

Identifier Type: -

Identifier Source: org_study_id