The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR)

Chronic Kidney Disease Clinical Trial

— BASE  

Official title:

The BASE Study: Bicarbonate Administration to Stabilize eGFR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521181
• Other study ID #: DK099877-B
• Secondary ID: U01DK099877
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Est. completion date: June 2018

Study information

• Verified date: October 2020
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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)

2. 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

3. Blood pressure <160/100 mm Hg at screening (must be <150/100 mm Hg prior to randomization)

4. Lean body weight 38.0-96.0 kg at the time of screening

5. Age allowing legal consent without parental involvement (18-21 years, depending on individual state regulations)

6. Able to provide consent

7. Able to travel to study visits

8. Able to read English

9. In the opinion of the site investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations

10. In the opinion of the site investigator, medically stable

Exclusion Criteria:

1. 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

2. On five or more antihypertensive and/or diuretic agents, regardless of the indication

3. Serum potassium <3.3 or =5.5 mEq/L at screening (must be 3.5-5.5 mEq/L prior to randomization)

4. Self-reported vegetarian

5. 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

6. Frequent urinary tract infections (=2 in the past year)

7. Presence of indwelling urinary catheter or urinary conduit (such as neobladder or urostomy)

8. 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)

9. Organ transplant recipients (excluding cornea)

10. Active glomerular disease requiring or potentially requiring immunosuppressive treatment

11. Chronic immunosuppressive therapy (for =3 months) for any indication. This does not include oral steroids <10 mg per day, inhaled steroids, or topical steroids

12. Anticipated initiation of dialysis or kidney transplantation within 12 months as assessed by the site investigator

13. Current participation in another interventional research study

14. Malignancy requiring therapy within 2 years (basal or squamous cell skin carcinoma and localized prostate cancer are exempted)

15. 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.

16. Life expectancy <12 months as determined by the site investigator

17. Institutionalized individuals, including prisoners and nursing home residents

18. Plans to leave the immediate area within the next 12 months

19. Routinely leaves town for multiple weeks each year such that protocol visits would be missed

20. Chronic use of supplemental oxygen

21. Use of both angiotensin-converting-enzyme inhibitor (ACEI) and Angiotensin II Receptor Blockers (ARBs)

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Lower Dose Sodium Bicarbonate
Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
• Higher Dose Sodium Bicarbonate
Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
• Placebo
Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Data Coordinating Center; Cleveland Clinic Foundation; Quantitative Health Sciences; 9500 Euclid Avenue	Cleveland	Ohio
United States	Denver Nephrology Research	Denver	Colorado
United States	University of Utah	Salt Lake City	Utah
United States	Utah VA	Salt Lake City	Utah
United States	Baylor/Scott & White	Temple	Texas
United States	George Washington University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Jennifer Gassman, PhD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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