Chronic Renal InsufficiencyNCT01574157
Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.
A study testing Sodium bicarbonate in people with Chronic Renal Insufficiency and Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Insufficiency, Diabetes Mellitus
- What is being tested?
- Sodium bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2012to 1 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
About this study
Official title: Investigations of the Optimum Serum Bicarbonate Level in Renal Disease
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.
Read the 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
- Being tested
- Sodium bicarbonate, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate | Active comparator | Participants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months Receives: Drug: Sodium bicarbonate |
| Placebo | Placebo comparator | Participants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)
Urinary TGF-b1 is considered a marker of renal fibrosis
Measured: The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.
Secondary outcomes (5)
Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)
KIM-1 is a marker of of kidney injury.
Measured: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)
NGAL is a marker of kidney injury
Measured: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Levels of Fibronectin
Fibronectin is a marker of kidney injury.
Measured: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Albumin Levels
Urinary albumin is a marker of kidney damage
Measured: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Estimated Glomerular Filtration (eGFR)
eGFR is a measure of kidney function
Measured: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study start5 Nov 2012
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kalani L Raphael, MD, Principal investigator, VA Salt Lake City Health Care System, Salt Lake City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574157
- Sponsor's protocol ID
- CLIN-002-11F
- Status last verified
- Aug 2019
- First submitted
- 27 Mar 2012
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35369374
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of the Optimum Serum Bicarbonate Level in Renal Disease
- ClinicalTrials.gov ID
- NCT01574157
- Acronym / sponsor ID
- CLIN-002-11F
- Conditions
- Chronic Renal Insufficiency, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 5 Nov 2012 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate | Active comparator | Drug: Sodium bicarbonateParticipants were prescribed 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily for six months |
| Placebo | Placebo comparator | Drug: PlaceboParticipants were prescribed an identical number of placebo tablets had they been assigned to the intervention, and took this daily for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateParticipants 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 | Sodium Bicarbonate |
| PlaceboParticipants 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. | Drug | Placebo |
Primary outcome
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 between the groups.
Urinary TGF-b1 is considered a marker of renal fibrosis
5 secondary outcomes
Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Levels of Fibronectin
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Urinary Albumin Levels
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Change in Estimated Glomerular Filtration (eGFR)
Time frame: The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35369374Gardner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalani L Raphael, MD principal investigator
VA Salt Lake City Health Care System, Salt Lake City, UT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate in people with Chronic Renal Insufficiency and Diabetes Mellitus, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 between the groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01574157, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.