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Antibiotic

Rifampin for Genetic Disorders Related to High Calcium Levels (RICHH Trial)

Phase 2
Recruiting
Led By Michael A Levine, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum and/or urinary calcium above the normal reference range for age
Presence of at least one mutation of CYP24A1
Must not have
Current therapies with medications that have significant drug-drug interactions with rifampin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8, 16, 24 and 32 weeks post-dose
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if a drug called rifampin can help people with a certain gene mutation who have high levels of calcium in their blood or urine.

Who is the study for?
This trial is for individuals aged 6 months to 65 years with genetic disorders causing high calcium in blood/urine due to CYP24A1 mutations. They must have normal or elevated vitamin D3 and low parathyroid hormone levels. Excluded are those allergic to rifampin, on conflicting meds, pregnant/breastfeeding, or with significant liver/kidney disease.
What is being tested?
The study tests the effectiveness of rifampin in treating high calcium levels in blood and urine linked to specific genetic mutations. Participants will take rifampin for 16 weeks to see if it helps manage their condition.
What are the potential side effects?
Rifampin may cause side effects such as allergic reactions, digestive issues like nausea or upset stomach, headaches, drowsiness, and possibly more serious liver problems indicated by yellowing skin or eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My calcium levels are higher than normal.
Select...
My tests show a CYP24A1 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not on medications that interact badly with rifampin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8, 16, 24 and 32 weeks post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8, 16, 24 and 32 weeks post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Serum albumin-adjusted calcium
Serum parathyroid hormone
Urinary calcium excretion
Secondary study objectives
Intestinal calcium absorption
Nephrocalcinosis
Rifampin pharmacokinetics

Side effects data

From 2019 Phase 2 trial • 97 Patients • NCT02024555
2%
Fever
2%
yeast infection
2%
joint pain and achiness
2%
Yeast Infection, (Urine Urgency, Fever, Joint Aches)
2%
leukopenia
2%
fever, chills
2%
Low WBC
2%
Pneumonia
2%
Ankle Fracture
2%
Hypotension
2%
Urine Color change
2%
SOB/Fatigue
2%
depression
2%
Fatigue
2%
Reaction to medication
2%
Joint pain
2%
Rash
2%
Cough, fever chills, pain with breathing
2%
Elevated Glucose
2%
diarrhea
2%
Tiredness/Fatigue
2%
Hospitalization
2%
Right Upper Quadant Pain
2%
diarrhea/loose stool
2%
nausea
2%
Low WBC Count
2%
increase in hair loss
2%
Insomnia
2%
flu-like symptoms (chills, aches, fatigue)
2%
confusion
2%
Anxiety, Insomnia
2%
weakness
2%
Dehydration
2%
Joint Stiffiness
2%
Anxiety
2%
elevated LFTs
2%
loss of appetite
2%
Nauseated, Vomiting & Diarrhea
2%
Syncope
2%
Shingles
2%
WBC Low
2%
Floater/Blurry Vision
2%
nausea, vomitting, diarrhea
2%
Neurosarcoidosis
2%
Low Platelet count
2%
Nausea, Vomiting, Diarrhea
2%
Fever, Nausea, Chills
2%
Leukopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: All SubjectsExperimental Treatment1 Intervention
SingleArm: Escalating doses of rifampin (5 and 10 mg/kg/day) (SingleArm)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifampin
2011
Completed Phase 3
~2140

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,472,974 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,359 Total Patients Enrolled
Michael A Levine, MDPrincipal InvestigatorChildren'sHospital of Philadelphia

Media Library

Rifampin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03301038 — Phase 2
Rifampin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03301038 — Phase 2
Idiopathic Infantile Hypercalcaemia Research Study Groups: All Subjects
Idiopathic Infantile Hypercalcaemia Clinical Trial 2023: Rifampin Highlights & Side Effects. Trial Name: NCT03301038 — Phase 2
~14 spots leftby Dec 2026
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