search
Back to results

Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

Primary Purpose

Calcium Phosphate Kidney Stones

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
OHCit- standard dose
Potassium Citrate
Placebo
OHCit- low dose
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Calcium Phosphate Kidney Stones focused on measuring Urolithiasis, Calcium phosphate, Citrate, Acid-base

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Calcium Phosphate stone formers Exclusion Criteria: History of recurrent urinary tract infections Chronic diarrhea Estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73 m2 History of primary hyperparathyroidism Hypokalemia Hyperkalemia Pregnancy

Sites / Locations

  • UT Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Potassium Citrate (Urocit®-K)

Super CitriMax; OHCit-standard dose

Super CitriMax; OHCit-low dose

Placebo

Arm Description

Potassium Citrate KCit 10 mEq 2 tabs, twice daily and Placebo 1 tab, twice daily Total Daily Dose: Citrate 40 mEq/d

Super CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d

Super CitriMax 7 mEq 2 tabs, twice daily And Placebo 1 tab, twice daily Total Daily Dose: OHCit 28 mEq/d

Placebo 3 tablets twice daily Total Daily Dose: None

Outcomes

Primary Outcome Measures

Formation product (FP) for Calcium Phosphate
FP is obtained by adding increasing amounts of Calcium Chloride (CaCl2) to a series of urine aliquots maintained at constant pH for 2 hours, and is identified by the point at which calcium phosphate (CaP) precipitates as detected by an absorbance microplate reader. Calculated supersaturation using [Calcium] and [Phosphate] at that point represents FP.

Secondary Outcome Measures

Crystal growth of Calcium Phosphate
We will assess crystal growth (CG) of CaP after seeding urine with a small amount of brushite (0.25 mg/ml urine) and incubating at 37°C for 3 hours (representing steady state) under constant stirring. A decrement in [Calcium]×[Phosphate] after seeding signifies crystal growth, while a [Calcium]×[Phosphate] increment represents crystal dissolution.
Calcium Phosphate supersaturation
Supersaturation of calcium phosphate will be assessed by Joint Expert Speciation System (JESS).

Full Information

First Posted
August 14, 2023
Last Updated
October 11, 2023
Sponsor
University of Texas Southwestern Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT06003348
Brief Title
Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
Official Title
Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2023 (Actual)
Primary Completion Date
May 31, 2028 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study tests whether hydroxycitrate, a molecule closely related to citrate, can reduce calcium phosphate stone recurrence.
Detailed Description
In this double-blind, placebo-controlled, randomized, crossover study, each participant will undergo 4 phases of study, with the order randomized by a blocked randomization scheme. The 4 phases will be Placebo, Super CitriMax (hydroxycitrate) OHCit low dose, OHCit standard dose, or Potassium Citrate. Randomization will be stratified based on sex, concomitant thiazide use, and concomitant alkali use. Each phase will be 1 week in duration, during which subjects will take assigned study medications. A minimum 1-week washout period will be imposed between phases. During the first 2 days of each phase, subjects will be instructed to adhere to a prescribed diet. On the last 5 days of each phase, subjects will be kept on a constant metabolic diet. Use of metabolic diet is essential to eliminate confounders that could occur from changes in dietary intake across phases. During the final two study days (days 6-7), two 24-hr urines will be collected for urine biochemistry and crystallization studies. Fasting blood will be obtained at the end of the last urine collection. Study Medications: Subjects will receive three tablets twice daily during each phase. These will consist of either placebo, Potassium Citrate (KCit), or Super CitriMax (OHCit). Study tablets will be prepared by a compounding pharmacy, with placebo tablets similar in appearance and size to the active medication tablets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcium Phosphate Kidney Stones
Keywords
Urolithiasis, Calcium phosphate, Citrate, Acid-base

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
In this double-blind, placebo-controlled, randomized, crossover study, each participant will undergo 4 phases of study, with the order randomized by a blocked randomization scheme. The 4 phases will be Placebo, Super CitriMax (OHCit) low dose, Super CitriMax (OHCit) standard dose, or Potassium Citrate. Randomization will be stratified based on sex, concomitant thiazide use, and concomitant alkali use.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Potassium Citrate (Urocit®-K)
Arm Type
Active Comparator
Arm Description
Potassium Citrate KCit 10 mEq 2 tabs, twice daily and Placebo 1 tab, twice daily Total Daily Dose: Citrate 40 mEq/d
Arm Title
Super CitriMax; OHCit-standard dose
Arm Type
Experimental
Arm Description
Super CitriMax 7 mEq 3 tabs, twice daily Total Daily Dose: OHCit 42 mEq/d
Arm Title
Super CitriMax; OHCit-low dose
Arm Type
Experimental
Arm Description
Super CitriMax 7 mEq 2 tabs, twice daily And Placebo 1 tab, twice daily Total Daily Dose: OHCit 28 mEq/d
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 3 tablets twice daily Total Daily Dose: None
Intervention Type
Dietary Supplement
Intervention Name(s)
OHCit- standard dose
Other Intervention Name(s)
Super Citrimax
Intervention Description
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
Intervention Type
Drug
Intervention Name(s)
Potassium Citrate
Other Intervention Name(s)
Urocit®-K
Intervention Description
10 mEq Extended-release tablets for oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
OHCit- low dose
Other Intervention Name(s)
Super Citrimax
Intervention Description
Hydroxycitrate Over-the-counter supplement, not FDA approved or regulated.
Primary Outcome Measure Information:
Title
Formation product (FP) for Calcium Phosphate
Description
FP is obtained by adding increasing amounts of Calcium Chloride (CaCl2) to a series of urine aliquots maintained at constant pH for 2 hours, and is identified by the point at which calcium phosphate (CaP) precipitates as detected by an absorbance microplate reader. Calculated supersaturation using [Calcium] and [Phosphate] at that point represents FP.
Time Frame
After 1 week of treatment
Secondary Outcome Measure Information:
Title
Crystal growth of Calcium Phosphate
Description
We will assess crystal growth (CG) of CaP after seeding urine with a small amount of brushite (0.25 mg/ml urine) and incubating at 37°C for 3 hours (representing steady state) under constant stirring. A decrement in [Calcium]×[Phosphate] after seeding signifies crystal growth, while a [Calcium]×[Phosphate] increment represents crystal dissolution.
Time Frame
After 1 week of treatment
Title
Calcium Phosphate supersaturation
Description
Supersaturation of calcium phosphate will be assessed by Joint Expert Speciation System (JESS).
Time Frame
After 1 week of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Calcium Phosphate stone formers Exclusion Criteria: History of recurrent urinary tract infections Chronic diarrhea Estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73 m2 History of primary hyperparathyroidism Hypokalemia Hyperkalemia Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NAIM M MAALOUF, MD
Phone
214/648-2954
Email
naim.maalouf@utsouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Miranda King
Phone
2146482117
Email
Miranda.King@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NAIM M MAALOUF
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8885
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naim M Maalouf, MD

12. IPD Sharing Statement

Learn more about this trial

Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones

We'll reach out to this number within 24 hrs