Your session is about to expire
← Back to Search
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 belowSelect...
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 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
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 • NCT020245552%
Fatigue
2%
weakness
2%
SOB/Fatigue
2%
diarrhea
2%
Urine Color change
2%
Fever
2%
Anxiety, Insomnia
2%
Pneumonia
2%
yeast infection
2%
joint pain and achiness
2%
Dehydration
2%
Ankle Fracture
2%
Hypotension
2%
depression
2%
Reaction to medication
2%
Rash
2%
Elevated Glucose
2%
Hospitalization
2%
increase in hair loss
2%
Insomnia
2%
leukopenia
2%
loss of appetite
2%
Right Upper Quadant Pain
2%
WBC Low
2%
Low WBC
2%
Floater/Blurry Vision
2%
nausea
2%
diarrhea/loose stool
2%
nausea, vomitting, diarrhea
2%
Tiredness/Fatigue
2%
flu-like symptoms (chills, aches, fatigue)
2%
fever, chills
2%
Yeast Infection, (Urine Urgency, Fever, Joint Aches)
2%
Syncope
2%
confusion
2%
Joint Stiffiness
2%
Anxiety
2%
elevated LFTs
2%
Nauseated, Vomiting & Diarrhea
2%
Joint pain
2%
Shingles
2%
Cough, fever chills, pain with breathing
2%
Neurosarcoidosis
2%
Low Platelet count
2%
Nausea, Vomiting, Diarrhea
2%
Fever, Nausea, Chills
2%
Low WBC Count
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
8,472,259 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,393 Total Patients Enrolled
Michael A Levine, MDPrincipal InvestigatorChildren'sHospital of Philadelphia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your liver or kidney function tests show significant abnormalities, with levels more than twice the normal limit for certain substances in the blood.I am between 6 months and 65 years old.I am not on medications that interact badly with rifampin.My calcium levels are higher than normal.My tests show a CYP24A1 mutation.You are allergic to rifampin or similar medications.Your blood test shows a low level of PTH (parathyroid hormone), less than 20 pg/ml.Your blood has either high or normal levels of 1,25-dihydroxyvitamin D3.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: All Subjects
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.