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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8, 16, 24 and 32 weeks post-dose

Awards & highlights

RICHH Trial 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.Check my eligibility

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.See study design

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.

RICHH Trial 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.

RICHH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8, 16, 24 and 32 weeks post-dose

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum albumin-adjusted calcium

Serum parathyroid hormone

Urinary calcium excretion

Secondary outcome measures

Intestinal calcium absorption

Nephrocalcinosis

Rifampin pharmacokinetics

Side effects data

From 2019 Phase 2 trial • 97 Patients • NCT02024555

Floater/Blurry Vision

Ankle Fracture

Nausea, Vomiting, Diarrhea

Pneumonia

diarrhea

Hypotension

Neurosarcoidosis

yeast infection

weakness

Tiredness/Fatigue

fever, chills

elevated LFTs

Leukopenia

loss of appetite

Reaction to medication

Joint pain

Right Upper Quadant Pain

joint pain and achiness

diarrhea/loose stool

flu-like symptoms (chills, aches, fatigue)

Low Platelet count

nausea

Hospitalization

Fever, Nausea, Chills

Fever

depression

Urine Color change

Dehydration

SOB/Fatigue

Rash

Cough, fever chills, pain with breathing

Shingles

Joint Stiffiness

confusion

Anxiety

leukopenia

Low WBC Count

WBC Low

Low WBC

Elevated Glucose

Nauseated, Vomiting & Diarrhea

nausea, vomitting, diarrhea

increase in hair loss

Fatigue

Syncope

Anxiety, Insomnia

Yeast Infection, (Urine Urgency, Fever, Joint Aches)

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin

Placebo

RICHH 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,582,790 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,562 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently open to new participants?

"According to clinicaltrials.gov, this medical trial is actively recruiting patients and was originally posted on the 25th of July 2018 with its latest update occurring on October 27th 2022."

Answered by AI

Has Rifampin been trialed in any other medical studies?

"Currently, there are 31 clinical trials that explore the effects of Rifampin. Of these, 11 have reached Phase 3 and 262 sites across Bandung and Alberta offer access to this medication."

Answered by AI

How many participants is this experiment accepting?

"Affirmative. Clinicaltrials.gov hosts data that confirms this medical trial, which was initially unveiled on July 25th 2018 is currently recruiting patients. 18 participants need to be sourced from one centre."

Answered by AI

What health concerns does Rifampin generally address?

"Rifampin is typically prescribed to manage MRSA infections, but also may alleviate pruritus, early-stage tuberculosis and nasopharynx issues."

Answered by AI

Has the Food and Drug Administration cleared Rifampin for commercial use?

"We ascribed a rating of 2 to Rifampin due to its Phase 2 status. This implies that there is some evidence bolstering safety but no data proving efficacy as of yet."

Answered by AI

Who has the opportunity to participate in this clinical experiment?

"This medical study requires 18 participants who are between 6 months and 65 years old. Furthermore, these patients must possess at least one mutation of CYP24A1, have a serum/urinary calcium level that is above the age-related reference range, exhibit a PTH concentration lower than 20 pg/ml and display either an elevated or normal 1,25-dihydroxyvitamin D3 serum concentration."

Answered by AI