- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05918029
Bone in CKD Alkali Response (BICARb Pilot Trial) (BICARb)
January 31, 2024 updated by: Albert Einstein College of Medicine
Bone in CKD Alkali Response Pilot Trial (BICARb)
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
Researchers will compare the bone imaging between the potassium citrate and the placebo groups at the end of the study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
103
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kimberly Reidy, MD
- Phone Number: 718-741-2450
- Email: kreidy@montefiore.org
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Recruiting
- Albert Einstein College Of Medicine
-
Contact:
- Lisandra Villalba
- Phone Number: 718-430-3301
- Email: lisandra.ninonuevo@einsteinmed.edu
-
Principal Investigator:
- Kimberly L Reidy, MD
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh Medical Center
-
Contact:
- Juhi Kumar, MD
-
Principal Investigator:
- Juhi Kumar, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 5 years old
- For children: Estimated eGFR >30 and <90 ml/min/1.73m2 by CKiD U25 (For Pediatric participants) equations
- For adults (≥18 years old): Estimated eGFR >30 and <90 ml/min/1.73m2 by the new CKD-Epi without race (For Adults)
- Females of child-bearing potential must have had a menstrual period in the last month
- For participants < 18 years, the participant and/or parent/guardian capable of providing informed consent and assent (assessed by the provider)
- Proficiency in English or Spanish
- PTH and phosphorus levels within the normal range
- 25-hydroxyvitamin D ≥ 20 ng/mL
- Women of childbearing potential must be willing to use one form of effective contraception over the course of the study
Exclusion Criteria:
- Baseline potassium > or = 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 > 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, 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
Oral potassium citrate
|
Placebo Comparator: Placebo
Placebo capsules identical to the active capsules.
|
Placebo capsule identical to active ingredient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total volumetric bone mineral density (BMD)
Time Frame: 6 months
|
Change in total volumetric bone mineral density (BMD) by high resolution peripheral quantitative computed tomography (HR-pQCT).
|
6 months
|
24 hour net Urine Acid Excretion (NAE)
Time Frame: 6 months
|
Change of urine acid excretion in 24-hour net Urine Acid Excretion (NAE)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in parathyroid hormone
Time Frame: 6 months
|
Change from baseline to 6 months in median parathyroid hormone levels
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of serum bicarbonate and urine NAE
Time Frame: 6 months
|
Correlation coefficient will be determined between serum bicarbonate and urine net acid excretion.
The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation.
|
6 months
|
Correlation of serum bicarbonate and bone quality
Time Frame: 6 months
|
Correlation coefficient will be determined between serum bicarbonate and bone quality.
The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation.
|
6 months
|
Correlation between urine net acid excretion and bone quality
Time Frame: 6 months
|
Correlation coefficient will be determined between urine net acid excretion and bone quality.
The correlation coefficient is a number between 0 and 1, with 0 being no correlation and 1 being perfect correlation.
|
6 months
|
Changes in bone alkaline phosphatase
Time Frame: 6 months
|
Changes in bone alkaline phosphatase will be compared between the groups.
Bone alkaline phosphatase is measured in IU/L.
Higher values are indicative of higher bone turnover.
|
6 months
|
Changes in TRAP5b
Time Frame: 6 months
|
Changes in TRAP5b compared between the groups.
TRAP5b are measured in mIU/mL.
|
6 months
|
Changes in bone quality
Time Frame: 6 months
|
Bone quality as measured by high resolution peripheral quantitative CT will be compared between groups
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kimberly Reidy, MD, Albert Einstein College Of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
June 2, 2023
First Submitted That Met QC Criteria
June 15, 2023
First Posted (Actual)
June 26, 2023
Study Record Updates
Last Update Posted (Actual)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Physiological Effects of Drugs
- Natriuretic Agents
- Diuretics
- Respiratory System Agents
- Expectorants
- Potassium Citrate
Other Study ID Numbers
- 2023-14826
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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