Testing potassium citrate for improving bone health in chronic kidney disease
Bone in CKD Alkali Response Pilot Trial (BICARb)
This study is testing if potassium citrate can help improve bone health in adults and children with chronic kidney disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 5 Years to 100 Years |
| Sex | All |
| Sponsor | Albert Einstein College of Medicine Academic / other |
| Drugs / interventions | denosumab, romosozumab, chemotherapy |
| Locations | 2 sites (The Bronx, New York and 1 other locations) |
| Trial ID | NCT05918029 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of potassium citrate on bone quality and strength in both adults and children with chronic kidney disease (CKD). Participants will undergo blood and urine tests, health and diet questionnaires, and advanced bone imaging over an 8-month period. The study includes a run-in phase followed by a randomized, placebo-controlled trial where participants will receive either potassium citrate or a placebo for 6 months. The goal is to determine if potassium citrate can mitigate bone loss associated with CKD.
Who should consider this trial
Good fit: Ideal candidates include children aged 5-17 and adults over 18 with chronic kidney disease and specific eGFR levels.
Not a fit: Patients with eGFR below 30 or those with severe bone disorders unrelated to CKD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve skeletal health and reduce fracture risk in patients with chronic kidney disease.
How similar studies have performed: While there is limited data on potassium citrate specifically for bone health in CKD, similar approaches targeting metabolic acidosis have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Pediatric Inclusion): * Children 5-17 years old * Estimated eGFR \>30 and \<90 ml/min/1.73m2 by CKiD U25 equations * Females of child-bearing potential must have had a menstrual period in the last month * Levels of PTH and alkaline phosphatase within 2x normal range and phosphorus within the normal range for age (per local laboratory reference assay) * 25-hydroxy Vitamin D ≥ 20 ng/mL * Females of child-bearing potential must be willing to use one form of effective contraception over the course of the study * Proficiency in English or Spanish * For participants \< 18 years, the participant and/or parent/guardian capable of providing informed consent and assent (assessed by the provider) Inclusion Criteria (Adult Inclusion): * Adults ≥ 18 years old * Estimated eGFR \>30 and \<90 ml/min/1.73m2 by the new CKD-Epi without race * Pre-menopausal women of childbearing age must have had a menstrual period in the last month * Levels of PTH and alkaline phosphatase within 2x normal range and phosphorus up to 5.0 mg/dL (per local laboratory reference assay) * Levels of 25-hydroxy Vitamin D ≥ 20 ng/mL * Women of childbearing potential must be willing to use one form of effective contraception over the course of the study * Proficiency in English or Spanish Exclusion Criteria (Pediatric and Adult): * Baseline potassium ≥ 5.5 mEq/L or prior history of hyperkalemia in the last 6 months (potassium \> 5.5 mEq/L) or currently taking a potassium lowering agent * Alkali therapy within the prior 12 months * Baseline ECG with abnormalities associated with increased risk of arrythmia, excluding left ventricular hypertrophy * Baseline serum bicarbonate levels \< 17 or ≥ 30 mEq/L * Serum calcium \< 8.6 mg/dL, adjusted for serum albumin * Significant comorbidity causing acid-base imbalance (e.g., active cancer requiring chemotherapy, chronic liver failure, moderate or severe chronic obstructive lung disease, New York Heart Association class 2 or greater congestive heart failure, obstructive sleep apnea requiring nightly continuous positive airway pressure, active glomerular disease requiring immunosuppressive therapy, intestinal malabsorption or celiac disease) * Plans to relocate out of the area in the next 3 months * Urine pH \> 8 or history of nephrolithiasis * Lower extremity amputations or non-ambulatory * Metabolic bone disease not related to CKD (e.g., Paget's disease, primary hyperparathyroidism) * Endocrinopathy: untreated hyper or hypothyroidism, Cushing's syndrome * Medical diseases that can affect therapy (severe myocardial damage, acute dehydration, delayed gastric emptying, esophageal compression, or intestinal obstruction or stricture) * Use of bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, raloxifene, estrogen or testosterone replacement therapy, or an unstable dose of glucocorticoids within the 12-months prior to enrollment * Previous bilateral wrist and tibia fractures * Solid or liquid organ transplant * On dialysis or with rapidly deteriorating kidney function or expectation for transplantation or initiation of dialysis in less than 3 months * Pregnancy or breastfeeding * Prisoners or institutionalized individuals * Unwillingness to provide informed consent
Where this trial is running
The Bronx, New York and 1 other locations
- Albert Einstein College of Medicine — The Bronx, New York, United States (Recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kimberly Reidy, MD — Albert Einstein College of Medicine
- Study coordinator: Kimberly Reidy, MD
- Email: kreidy@montefiore.org
- Phone: 718-655-1120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.