Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated 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
Estimated Primary Completion Date :	July 1, 2018
Estimated Study Completion Date :	July 1, 2018

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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; Placebo	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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. ]
   Urinary TGF-b1 is considered a marker of renal fibrosis

Secondary Outcome Measures :

1. 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. ]
   These are biomarkers of renal complement system activation

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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 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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01574157 History of Changes
Other Study ID Numbers:	CLIN-002-11F
First Posted:	April 10, 2012
Last Update Posted:	November 17, 2017
Last Verified:	November 2017
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:

Diabetes Mellitus; Kidney Diseases; Renal Insufficiency; Renal Insufficiency, Chronic	Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Urologic Diseases