Bone in CKD Alkali Response (BICARb Pilot Trial)

Launched by ALBERT EINSTEIN COLLEGE OF MEDICINE · Jun 15, 2023

Keywords

ClinConnect Summary

The Bone in CKD Alkali Response (BICARb Pilot Trial) is a study designed to see if a medication called potassium citrate can help improve bone health in adults and children with chronic kidney disease (CKD). The researchers want to understand how potassium citrate might make bones stronger and healthier. Participants in this study will be asked to provide blood and urine samples, answer questions about their health and diet, and undergo special scans to assess their bone quality over an eight-month period. Half of the participants will receive potassium citrate, while the other half will receive a placebo (a pill with no active ingredients) during the six-month main part of the study.

To be eligible for this trial, participants should be between 5 and 100 years old with specific kidney function levels and health requirements. For example, they need to have certain blood test results within a normal range, and women of childbearing age must agree to use contraception during the study. Participants can expect to take study pills for a short period at the beginning to ensure safety, followed by the main treatment phase. This study is currently recruiting participants, and it’s important for anyone interested to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility 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