RECRUITING

Rifampin in CYP24A1-related Hypercalcemia and Hypercalciuria

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Conditions

Idiopathic Infantile Hypercalcaemia - Severe FormGenetic DiseaseHypercalcemia, Idiopathic, of InfancyHypercalciuric HypercalcemiaIdiopathic Infantile Hypercalcemia - Mild FormHypercalciuriahypercalcemianephrocalcinosisCYP24A1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Rifampin to Reduce Elevated Levels of Blood and Urine Calcium in Patients With Inactivating Mutations in the CYP24A1 Gene

Quick Facts

Study Start:2018-07-25
Study Completion:2030-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03301038

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.

Ages Eligible for Study:6 Months to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or females age 6 months to 65 years.
  2. * at least one mutations of CYP24A1
  3. * Serum and/or urinary calcium above the normal reference range for age
  4. * Serum PTH concentration \<20 pg/ml
  5. * Elevated or normal serum concentration of 1,25-dihydroxyvitamin D3.
  1. * Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
  2. * Allergy to rifampin or related medications
  3. * Current therapies with medications that have significant drug-drug interactions with rifampin, defined as a medication considered to interact with CYP3A4 or CYP3A5 and either induce or inhibit expression or function of these P450 enzymes. By "drug-drug" interactions we are looking for medications that will affect metabolism or action of rifampin as exclusionary, not medications that will be affected by rifampin.
  4. * Pregnancy or breastfeeding
  5. * Laboratory abnormalities that indicate clinically significant hepatic, or renal disease:

Contacts and Locations

Study Contact

Michael A Levine, MD
CONTACT
267-426-3907
levinem@chop.edu
Vashisht Arshanapally
CONTACT
267-426-7482
arshanapav@chop.edu

Principal Investigator

Michael A Levine, MD
PRINCIPAL_INVESTIGATOR
Children'sHospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

  • Michael A Levine, MD, PRINCIPAL_INVESTIGATOR, Children'sHospital of Philadelphia

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 Registration Dates

Study Start Date2018-07-25
Study Completion Date2030-12

Study Record Updates

Study Start Date2018-07-25
Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

  • hypercalcemia
  • nephrocalcinosis
  • CYP24A1
  • hypercalciuria

Additional Relevant MeSH Terms

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