Actively Recruiting
Bone in CKD Alkali Response (BICARb Pilot Trial)
Led by Albert Einstein College of Medicine · Updated on 2024-10-15
103
Participants Needed
2
Research Sites
102 weeks
Total Duration
On this page
Sponsors
A
Albert Einstein College of Medicine
Lead Sponsor
C
Columbia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test whether potassium citrate improves skeletal health in adults and children with chronic kidney disease. The main questions it aims to answer are: * To evaluate effects of potassium citrate treatment on bone quality and strength. * To evaluate mechanism(s) underlying the effects of potassium citrate on skeletal health. Participants will be asked to: * provide blood, urine and answer questions about health and diet three times during an 8 months period * undergo advanced bone imaging with high resolution-peripheral quantitative CT scan twice during 8 months * take study pills for 4-6 weeks at the beginning of the study to ensure safety * take either potassium citrate or placebo for 6 months during the blinded portion of the study As part of the study, there will be a run-in period followed by the placebo-controlled randomized clinical trial. Researchers will compare the bone imaging between the potassium citrate and the placebo groups at the end of the study.
CONDITIONS
Official Title
Bone in CKD Alkali Response (BICARb Pilot Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 17 years
- Adults aged 18 years and older
- Estimated eGFR greater than 30 and less than 90 ml/min/1.73m2
- Females of childbearing potential must have had a menstrual period in the last month
- Levels of parathyroid hormone (PTH) and alkaline phosphatase within twice the normal range
- Phosphorus levels within normal range for age (children) or up to 5.0 mg/dL (adults)
- 25-hydroxy Vitamin D level of at least 20 ng/mL
- Females of childbearing potential must agree to use one form of effective contraception during the study
- Proficiency in English or Spanish
- For participants under 18 years, participant and/or parent or guardian able to provide informed consent and assent
You will not qualify if you...
- Baseline potassium level of 5.5 mEq/L or higher, history of hyperkalemia in the last 6 months, or currently taking potassium-lowering medication
- Alkali therapy within the previous 12 months
- Baseline ECG abnormalities linked to higher risk of arrhythmia, excluding left ventricular hypertrophy
- Serum bicarbonate levels below 17 or equal to or above 30 mEq/L
- Serum calcium below 8.6 mg/dL (adjusted for serum albumin)
- Serious conditions causing acid-base imbalance such as active cancer requiring chemotherapy, chronic liver failure, moderate to severe chronic obstructive lung disease, significant heart failure, obstructive sleep apnea needing nightly CPAP, active glomerular disease needing immunosuppressive treatment, intestinal malabsorption or celiac disease
- Plans to move out of the area within 3 months
- Urine pH above 8 or history of kidney stones
- Lower limb amputations or inability to walk
- Metabolic bone diseases unrelated to CKD (e.g., Paget's disease, primary hyperparathyroidism)
- Untreated endocrine disorders such as hyperthyroidism, hypothyroidism, or Cushing's syndrome
- Medical conditions affecting therapy like severe heart damage, acute dehydration, delayed stomach emptying, esophageal compression, or intestinal obstruction
- Use of certain bone medications or unstable glucocorticoid doses within 12 months before enrollment
- Previous bilateral wrist and tibia fractures
- Organ transplant recipients
- On dialysis or with rapidly worsening kidney function or expected dialysis or transplant within 3 months
- Pregnancy or breastfeeding
- Prisoners or institutionalized individuals
- Unwillingness to provide informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Albert Einstein College of Medicine
The Bronx, New York, United States, 10461
Actively Recruiting
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
K
Kimberly Reidy, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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