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New treatment option for Chronic Kidney Diseases
Official title Bone in CKD Alkali Response (BICARb Pilot Trial)
ClinicalTrials.gov ID: NCT05918029
What this study is testing
What is Potassium Citrate Extended Release Oral Tablet?
Potassium Citrate Extended Release Oral Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 8 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 100
You may be able to join if
- (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)
You likely can't join if
- (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...
- 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
See the full eligibility 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) (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
- (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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.