Bone in CKD Alkali Response (BICARb Pilot Trial)

NCT ID: NCT05918029

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2026-08-31

Brief Summary

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.

Detailed Description

Chronic kidney disease is associated with bone loss and fractures in both children and adults, but bone protective therapies that are both proven and safe to use across the life-course in CKD are lacking. In this study, the investigators will conduct a pilot, double-blinded, randomized, placebo-controlled trial in 15 children and 88 adults evaluating the skeletal effects of potassium alkali therapy. These data will form the basis for a larger U01 proposal to determine the efficacy of potassium citrate on mitigating the effects of CKD on bone.

Conditions

Chronic Kidney Diseases; Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Potassium Citrate

Potassium Citrate extended-release tablets 30 mEq twice daily. 1 mEq/kg/day divided into two doses for children to a maximum dose of 30 mEq twice daily.

OR

(for children who cannot take pills): Potassium citrate and citric acid for oral solution 1 mEq/kg/day divided into two doses to a maximum dose of 30 mEq twice daily

Group Type: EXPERIMENTAL

Potassium Citrate Extended Release Oral Tablet

Intervention Type: DRUG

Oral potassium citrate extended-release tablet

Potassium Citrate and Citric Acid Oral Solution

Intervention Type: DRUG

Oral potassium citrate and citric acid

Placebo

Placebo capsules identical to the active capsules.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo capsule identical to active ingredient

Interventions

Potassium Citrate Extended Release Oral Tablet

Oral potassium citrate extended-release tablet

Intervention Type: DRUG

Placebo

Placebo capsule identical to active ingredient

Intervention Type: OTHER

Potassium Citrate and Citric Acid Oral Solution

Oral potassium citrate and citric acid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly Reidy, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status: RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kimberly Reidy, MD

Role: CONTACT

kreidy@montefiore.org

718-655-1120

Facility Contacts

Jordan Nacimba

Role: primary

jordan.nacimba@einsteinmed.edu

718-430-3301

Juhi Kumar, MD

Role: primary

References

Kilduff S, Brown DD, Melamed ML. Treating Metabolic Acidosis for CKD Progression? Need for Higher Quality Data. Clin J Am Soc Nephrol. 2025 Jan 1;20(1):147-149. doi: 10.2215/CJN.0000000632. Epub 2024 Nov 20. No abstract available.

Reference Type: DERIVED

PMID: 39665575 (View on PubMed)

Other Identifiers

2023-14826

Identifier Type: -

Identifier Source: org_study_id

R01DK131811

Identifier Type: NIH

Identifier Source: secondary_id

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