- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02521181
The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE)
October 19, 2020 updated by: Jennifer Gassman, PhD
The BASE Study: Bicarbonate Administration to Stabilize eGFR
The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight (LBW) per day.
Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chronic kidney disease.
However, the dose to prescribe in order to test this possibility in a clinical trial is uncertain.
The BASE pilot clinical trial will help determine the best dose of sodium bicarbonate to prescribe in a future study that will test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney function in individuals with chronic kidney disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
194
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80230
- Denver Nephrology Research
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20037
- George Washington University
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Ohio
-
Cleveland, Ohio, United States, 44195-5196
- Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue
-
-
Texas
-
Temple, Texas, United States, 76502
- Baylor/Scott & White
-
-
Utah
-
Salt Lake City, Utah, United States, 84112
- University of Utah
-
Salt Lake City, Utah, United States, 84112
- Utah VA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Serum bicarbonate 20-28 mEq/L at screening (the average of the two most recent values in Baseline must be 20-28 mEq/L prior to randomization)
Moderate to severe chronic kidney disease (CKD) at the time of screening, defined as one of the following:
- eGFR 20-44 ml/min/1.73m2 or
- eGFR 45-59 ml/min/1.73m2 plus random urinary albumin:creatinine (ACR) ≥100 mg/gm
- Blood pressure <160/100 mm Hg at screening (must be <150/100 mm Hg prior to randomization)
- Lean body weight 38.0-96.0 kg at the time of screening
- Age allowing legal consent without parental involvement (18-21 years, depending on individual state regulations)
- Able to provide consent
- Able to travel to study visits
- Able to read English
- In the opinion of the site investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations
- In the opinion of the site investigator, medically stable
Exclusion Criteria:
- Use of chronic daily oral alkali (such as sodium bicarbonate, sodium citrate, potassium citrate, etc) with one exception: calcium carbonate ≤1500 mg/day is allowed, as some will take this for the indication of bone health
- On five or more antihypertensive and/or diuretic agents, regardless of the indication
- Serum potassium <3.3 or ≥5.5 mEq/L at screening (must be 3.5-5.5 mEq/L prior to randomization)
- Self-reported vegetarian
- New York Heart Association Class 3 or 4 heart failure symptoms, known left ventricular ejection fraction ≤30%, or hospital admission for heart failure within the past 3 months
- Frequent urinary tract infections (≥2 in the past year)
- Presence of indwelling urinary catheter or urinary conduit (such as neobladder or urostomy)
- Factors judged to limit adherence to interventions (e.g., alcoholism, history of missing clinic visits, chronic gastrointestinal disorder that makes compliance with the intervention unreliable)
- Organ transplant recipients (excluding cornea)
- Active glomerular disease requiring or potentially requiring immunosuppressive treatment
- Chronic immunosuppressive therapy (for ≥3 months) for any indication. This does not include oral steroids <10 mg per day, inhaled steroids, or topical steroids
- Anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by the site investigator
- Current participation in another interventional research study
- Malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)
- Pregnancy or planning to become pregnant or currently breast-feeding. Women of childbearing potential (pre-menopausal and not surgically sterilized) will have urine pregnancy test before enrollment.
- Life expectancy <12 months as determined by the site investigator
- Institutionalized individuals, including prisoners and nursing home residents
- Plans to leave the immediate area within the next 12 months
- Routinely leaves town for multiple weeks each year such that protocol visits would be missed
- Chronic use of supplemental oxygen
- Use of both angiotensin-converting-enzyme inhibitor (ACEI) and Angiotensin II Receptor Blockers (ARBs)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lower Dose Sodium Bicarbonate
Participants will receive oral 0.5 milliequivalents (mEq)/kg-lean body weight (LBW)/day of sodium bicarbonate.
Half of the total daily dose is taken in the morning and the other half is taken in the evening.
(If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
|
Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
|
Experimental: Higher Dose Sodium Bicarbonate
Participants will receive 0.8 mEq/kg-LBW/day of sodium bicarbonate.
Half the total daily dose is taken in the morning and the other half is taken in the evening.
(If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
|
Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
|
Placebo Comparator: Placebo
Participants will take the same number of placebo capsules as if they were assigned to receive either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of sodium bicarbonate.
Half the total daily dose is taken in the morning and the other half is taken in the evening.
(If the number of capsules is an odd number, the greater number of capsules will be taken in the morning.)
|
Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants in Each Dose Arm Prescribed (i) Full Randomized Sodium Bicarbonate Dose at End of 28 Weeks & (ii) at Least 25% of Randomized Sodium Bicarbonate Dose at End of 28 Weeks as a Proportion of the Number Randomized to That Group
Time Frame: Baseline, 28 weeks
|
The prescribed dose for each participant at the end of 28 weeks will be determined by the safety and tolerability of each dose during the intervention period.
The primary assessments will examine the percentage of participants in each dose arm who are prescribed (i) the full randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks and (ii) at least 25% of the randomized sodium bicarbonate dose according to the protocol at the end of 28 weeks.
The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight per day.
|
Baseline, 28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Michael F. Flessner, MD, PhD, DKUHD, NIDDK, NIH
- Study Director: John W. Kusek, PhD, DKUHD, NIDDK, NIH
- Study Chair: Linda Fried, MD, MPH, VA Pittsburgh Healthcare System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
June 1, 2018
Study Registration Dates
First Submitted
April 27, 2015
First Submitted That Met QC Criteria
August 7, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Actual)
October 20, 2020
Last Update Submitted That Met QC Criteria
October 19, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK099877-B
- U01DK099877 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Disease
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
-
Centre Hospitalier Saint Joseph Saint Luc de LyonNot yet recruitingKidney Failure, Chronic | Diet Habit | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 3B | Chronic Kidney Disease, Stage 3 (Moderate) | Chronic Kidney Disease Stage 3A (Disorder)France
-
A.C. AbrahamsCompletedEnd Stage Renal Disease | Chronic Kidney Disease | End Stage Kidney Disease | Chronic Kidney FailureNetherlands
-
Far Eastern Memorial HospitalActive, not recruitingMetabolic Syndrome | Chronic Disease | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease Stage 3 | Chronic Kidney Disease Stage 4 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
Clinical Trials on Lower Dose Sodium Bicarbonate
-
Prim. Priv. Doz. Dr. Daniel CejkaMedice Arzneimittel Pütter GmbH & Co KGWithdrawnKidney Transplant; ComplicationsAustria
-
Sheba Medical CenterUnknownExtravasation | InfiltrationIsrael
-
GlaxoSmithKlineCompleted
-
Guy's and St Thomas' NHS Foundation TrustUniversity of PittsburghNot yet recruitingCovid19 | Acute Kidney Injury
-
Lars Wiuff AndersenUniversity of AarhusRecruiting
-
University of UtahThe University of Utah Center on AgingTerminatedChronic Kidney DiseaseUnited States
-
Kaiser PermanenteCompletedKidney Diseases | Contrast Induced NephropathyUnited States
-
Instituto Nacional de Cardiologia Ignacio ChavezUnknownAcute Kidney FailureMexico
-
Wake Forest University Health SciencesCompletedRenal Replacement Therapy | Kidney Failure, AcuteUnited States
-
Erasmus Medical CenterCompletedChronic Kidney DiseaseNetherlands