Rifampin in CYP24A1-related Hypercalcemia and Hypercalciuria

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT03301038
Phase
PHASE2
Status
Recruiting
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Conditions

  • Genetic Disease
  • Hypercalcemia, Idiopathic, of Infancy
  • Hypercalciuria
  • Hypercalciuric Hypercalcemia
  • Idiopathic Infantile Hypercalcaemia - Severe Form
  • Idiopathic Infantile Hypercalcemia - Mild Form

Eligibility Criteria

Sex
ALL
Age
6 Months - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rifampin — DRUG
    Rifampin 5 mg/kg (max 300 mg) daily for 8 weeks, followed by rifampin 10 mg/kg (max 600 mg) daily for 8 weeks.

Study Details

This study evaluates the efficacy of rifampin in the treatment of hypercalcemia and/or hypercalciuria in participants with at least one inactivating mutation of the CYP24A1 gene. Eligible subjects will receive rifampin for a total of 16 weeks during this study.

Key Dates

Start date
Jul 25, 2018
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Subjects
    SingleArm: Escalating doses of rifampin (5 and 10 mg/kg/day) (SingleArm)

Primary Outcome Measure

Serum albumin-adjusted calcium [ Time Frame: up to 32 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Michael A Levine, MD
[email protected]
267-426-3907
Sara Pinney, MD
[email protected]
215-590-3174
Sara Pinney, MD (SUB_INVESTIGATOR)
Michael A Levine, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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