Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

Tracking Information
First Submitted Date ICMJE	March 27, 2012
First Posted Date ICMJE	April 10, 2012
Last Update Posted Date	September 6, 2018
Actual Study Start Date ICMJE	November 5, 2012
Actual Primary Completion Date	May 1, 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 5, 2012)	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
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01574157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 5, 2012)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
Official Title ICMJE	Investigations of the Optimum Serum Bicarbonate Level in Renal Disease
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Chronic Renal Insufficiency; Diabetes Mellitus
Intervention ICMJE	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.; 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.
Study Arms	Active Comparator: Arm 1 Sodium bicarbonate Intervention: Drug: Sodium bicarbonate; Placebo Comparator: Arm 2 Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 5, 2012)	74
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	May 1, 2018
Actual Primary Completion Date	May 1, 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01574157
Other Study ID Numbers ICMJE	CLIN-002-11F
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	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
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	VA Office of Research and Development
Study Sponsor ICMJE	VA Office of Research and Development
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Kalani L Raphael, MD VA Salt Lake City Health Care System, Salt Lake City, UT
PRS Account	VA Office of Research and Development
Verification Date	September 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP