Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01574157
First received: March 27, 2012
Last updated: February 6, 2015
Last verified: February 2015
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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:
Further study details as provided by Department of Veterans Affairs:
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 2016 |
| Estimated Primary Completion Date: | July 2016 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Veteran
- Age older than 18 years
- Type II 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
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
Investigators
| Principal Investigator: | Kalani L. Raphael, MD | VA Salt Lake City Health Care System, Salt Lake City, UT |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01574157 History of Changes |
| Other Study ID Numbers: | CLIN-002-11F |
| Study First Received: | March 27, 2012 |
| Last Updated: | February 6, 2015 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015