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Potassium Citrate for Kidney Disease (BICARb Trial)
Phase 2 & 3
Recruiting
Led By Michal Melamed, MD
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For children: Estimated eGFR >30 and <90 ml/min/1.73m2 by CKiD U25 (For Pediatric participants) equations
Females of child-bearing potential must have had a menstrual period in the last month
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
BICARb Trial Summary
This trial tests if potassium citrate can improve bone health in adults & kids with kidney disease. Participants will provide blood & urine samples, answer health/diet questions & take either potassium citrate or placebo for 6 months. Results from bone imaging will be compared.
Who is the study for?
This trial is for adults and children over 5 with chronic kidney disease who have normal PTH, phosphorus, and vitamin D levels. Women must use contraception and not be pregnant or breastfeeding. Participants can't join if they have certain metabolic bone diseases, high potassium levels, heart risks on ECG, severe other illnesses affecting acid-base balance, a history of kidney stones or limb amputations.Check my eligibility
What is being tested?
The study tests if potassium citrate improves bone health in those with chronic kidney disease by comparing it to a placebo. Over 8 months, participants will take pills for safety checks then either the treatment or placebo for 6 months while undergoing blood tests, diet surveys, and advanced bone scans.See study design
What are the potential side effects?
While the description doesn't list specific side effects of potassium citrate in this context directly; generally it may cause digestive discomfort like nausea or diarrhea and increase the risk of developing high blood potassium levels which could affect heart rhythm.
BICARb Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child's kidney function is moderately reduced but not severely.
Select...
I have had a menstrual period in the last month.
Select...
I am 5 years old or older.
Select...
My kidney function is moderately reduced but not severely.
BICARb Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
24 hour net Urine Acid Excretion (NAE)
Total volumetric bone mineral density (BMD)
Secondary outcome measures
Changes in parathyroid hormone
Other outcome measures
Changes in TRAP5b
Changes in bone alkaline phosphatase
Changes in bone quality
+3 moreSide effects data
From 2011 Phase 4 trial • 83 Patients • NCT0035733119%
Gastrointestinal Symptoms
5%
Hyperkalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Potassium Citrate
Placebo
BICARb Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Potassium CitrateExperimental Treatment1 Intervention
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).
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules identical to the active capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Potassium citrate
2007
Completed Phase 2
~190
Find a Location
Who is running the clinical trial?
University of UtahOTHER
1,100 Previous Clinical Trials
1,778,798 Total Patients Enrolled
University of Pittsburgh Medical CenterOTHER
70 Previous Clinical Trials
76,147 Total Patients Enrolled
Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,005 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a solid or liquid organ transplant.I have had fractures in both my wrists and shins.My potassium levels are high or I've had high potassium in the last 6 months.My child's kidney function is moderately reduced but not severely.I do not have a bone disease unrelated to kidney issues.I have untreated thyroid issues or Cushing's syndrome.My urine is very alkaline or I have had kidney stones.I have had a lower limb amputated or I cannot walk.I do not have severe heart issues, dehydration, stomach or esophagus problems that could affect treatment.I have had a menstrual period in the last month.I haven't used specific bone or hormone treatments in the last year.I have not had alkali therapy in the last year.Your initial heart test shows irregularities that may increase the risk of heart rhythm problems, not including a condition called left ventricular hypertrophy.I have a serious health condition that affects my body's acid-base balance.I am proficient in English or Spanish.I am under 18 and can give consent with my parent or guardian.Your blood test shows that your bicarbonate levels are too low or too high.Your blood calcium level is less than 8.6 mg/dL when adjusted for your albumin level.My kidney function is rapidly declining, or I am on dialysis or expect to start dialysis or have a transplant soon.I am 5 years old or older.Your 25-hydroxyvitamin D level is at least 20 nanograms per milliliter.My kidney function is moderately reduced but not severely.Your parathyroid hormone (PTH) and phosphorus levels are normal.
Research Study Groups:
This trial has the following groups:- Group 1: Potassium Citrate
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who could potentially benefit from participating in this trial?
"This medical study is seeking 103 participants suffering from chronic kidney disease, aged between 5 and 100."
Answered by AI
Is this research initiative seeking participants over four decades of age?
"This clinical trial is only open to candidates between the ages of 5 and 100. Additionally, there are 50 trials for those under 18 years old, and an additional 516 studies available for those over 65."
Answered by AI
Is there presently a call for participants in this experiment?
"Information found on clinicaltrials.gov attests that this research trial is not currently recruiting patients. This study was first published on July 1, 2023 and the last update occurred June 15th of the same year. However, there are 568 other medical trials actively seeking candidate participation at this present time."
Answered by AI
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