Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

This study is currently recruiting participants. (see Contacts and Locations)

Verified July 2016 by VA Office of Research and Development

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT01574157

First received: March 27, 2012

Last updated: July 11, 2016

Last verified: July 2016

History of Changes

Purpose

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:

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Sodium bicarbonate

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:

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 2018
Estimated Primary Completion Date:	July 2018 (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 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.

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.

Eligibility


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

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 ClinicalTrials.gov identifier: NCT01574157

Contacts


Contact: Kalani L Raphael, MD	(801) 582-1565 ext 1234	Kalani.Raphael@va.gov

Locations


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 Kalani.Raphael@va.gov
Principal Investigator: Kalani L Raphael, MD

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


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01574157 History of Changes
Other Study ID Numbers:	CLIN-002-11F
Study First Received:	March 27, 2012
Last Updated:	July 11, 2016
Health Authority:	United States: Federal Government
Individual Participant Data
Plan to Share IPD:	No

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 29, 2016

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