Treating Metabolic Acidosis for CKD Progression? Need for Higher Quality Data.
Stella Kilduff, Denver D Brown, Michal L Melamed
https://pubmed.ncbi.nlm.nih.gov/39665575Actively Recruiting
Phase 2
Phase 3
Age: 5Years - 100Years
All Genders
ID05918029
Bone in CKD Alkali Response Pilot Trial Evaluating Potassium Citrate for Bone Health in Children and Adults
Led by Albert Einstein College of Medicine · Updated on 2024-10-15
103
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating whether potassium citrate can improve bone health in children and adults with chronic kidney disease (CKD), a condition linked to bone loss and fractures. This pilot, double-blinded, randomized, placebo-controlled trial aims to assess the effects of potassium citrate on bone quality and strength, as well as to understand the biological mechanisms behind these effects. The study includes 15 children and 88 adults and will provide data for a larger future trial on potassium citrate's role in protecting bone in CKD. Participants will receive either potassium citrate in extended-release tablet form or an oral solution for children unable to take pills, or a matching placebo. Dosage for children is 1 mEq/kg/day divided into two doses up to 30 mEq twice daily, while adults take 30 mEq twice daily. The study begins with a 4-6 week safety run-in period, followed by a 6-month blinded treatment phase comparing potassium citrate to placebo. Advanced bone imaging using high-resolution peripheral quantitative CT scans will be performed twice during the 8-month study. During the 8 months of participation, participants will provide blood and urine samples and answer questions about their health and diet at three time points. Bone density changes at the radius and tibia will be measured as primary outcomes. Secondary outcomes include changes in urine acid levels, parathyroid hormone, and bone turnover biomarkers. Safety and adherence will be monitored regularly throughout the study period.
CONDITIONS
Brief Title
Bone in CKD Alkali Response (BICARb Pilot Trial)
Who Can Participate
Age: 5Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children 5-17 years old
- Adults 18 years and older
- Estimated eGFR greater than 30 and less than 90 ml/min/1.73m2
- Females of child-bearing potential must have had a menstrual period in the last month
- Parathyroid hormone and alkaline phosphatase levels within twice the normal range
- Phosphorus within the 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 child-bearing potential must be willing to use effective contraception during the study
- Proficiency in English or Spanish
- For participants under 18, the participant and/or parent/guardian must be able to provide informed consent and assent
You will not qualify if you...
- Baseline potassium level of 5.5 mEq/L or higher or history of high potassium in the past 6 months
- Current use of potassium lowering agents
- Alkali therapy within the past 12 months
- Abnormal baseline ECG associated with increased risk of arrhythmia, excluding left ventricular hypertrophy
- Baseline serum bicarbonate less than 17 or 30 mEq/L or higher
- Serum calcium less than 8.6 mg/dL (adjusted for albumin)
- Significant other illnesses causing acid-base imbalance such as active cancer needing chemotherapy, chronic liver failure, moderate/severe COPD, advanced heart failure, sleep apnea requiring CPAP, active glomerular disease needing immunosuppressive therapy, or intestinal malabsorption
- Plans to move away within 3 months
- Urine pH over 8 or history of kidney stones
- Lower limb amputations or inability to walk
- Bone diseases not related to CKD like Paget's disease or primary hyperparathyroidism
- Untreated thyroid disorders or Cushing's syndrome
- Medical conditions affecting therapy like severe heart damage or intestinal obstruction
- Use of certain bone medications or unstable glucocorticoid doses within 12 months
- Previous bilateral wrist and tibia fractures
- Organ transplant recipients
- On dialysis or expected to start dialysis or transplant within 3 months
- Pregnancy or breastfeeding
- Prisoners or institutionalized individuals
- Unwillingness to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive potassium citrate or placebo to evaluate effects on bone health in chronic kidney disease.
Regular visits during treatment period
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
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Research Team
K
Kimberly Reidy, MD
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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