ACTHAR Gel (adrenocorticotropic hormone) for Hypercalcemia Due to Sarcoidosis

1
Effectiveness
2
Safety
Albany Medical College, Albany, NY
+2 More
ACTHAR Gel (adrenocorticotropic hormone) - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hypercalcemia Due to Sarcoidosis

Study Summary

ACTHAR GEL for Sarcoidosis-Associated Calcium Dysregulation: An Open-label Pilot Study

See full description

Eligible Conditions

  • Sarcoidosis
  • Hypercalcemia
  • Hypercalcemia Due to Sarcoidosis

Treatment Effectiveness

Study Objectives

This trial is evaluating whether ACTHAR Gel (adrenocorticotropic hormone) will improve 1 primary outcome and 9 secondary outcomes in patients with Hypercalcemia Due to Sarcoidosis. Measurement will happen over the course of Baseline compared to 12 weeks..

Week 12
Change in 1,25 di-hydroxy Vitamin D during 12 week ACTHAR GEL treatment
Change in serum calcium during 12 week ACTHAR GEL treatment
Baseline to 12 Weeks
Change in Sarcoidosis Health Questionnaire during 12 week ACTHAR GEL treatment
Change in Short Form-36 during 12 week ACTHAR GEL treatment
Change in adjusted eCOST (eCOSTadj) calculated as the eCOST/# organs with an eCOST score > 022 during 12 week ACTHAR gel treatment
Change in eCOST during 12 week ACTHAR gel treatment
Change in physician global VAS during 12 week ACTHAR GEL treatment
Change in urinary symptoms during 12 week ACTHAR GEL treatment
Baseline to 12 weeks
Change in patient global VAS during 12 week ACTHAR GEL treatment
Week 12
Reduction of 24 hour urine calcium

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Sarcoidosis related Calcium Dysregulation

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. ACTHAR Gel (adrenocorticotropic Hormone) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Sarcoidosis related Calcium Dysregulation
Drug
Subjects with Sarcoidosis associated calcium dysregulation will be administered 80 units of Acthar Gel (adrenocorticotropic hormone) twice a week for 12 weeks. Clinical visits will be scheduled for -30 days, day of 1st dose and 4,8,12 and 16 week after 1st dose to monitor the health of subjects.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to 12 weeks for reporting.

Who is running the study

Principal Investigator
M. A. J.
Marc A. Judson, MD
Albany Medical College

Closest Location

Albany Medical College - Albany, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age greater than 18 years old.
Able to understand English to the point of comprehending the informed consent form.
Biopsy proven sarcoidosis.
Documented hypercalciuria (urinary excretion of > 4mg/kg of calcium/day) or hypercalcemia within 4 weeks of study entry.
Historical evidence that the patient's hypercalciuria/hypercalcemia is related to sarcoidosis. This should include a serum parathyroid hormone (PTH) level which is not elevated.

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Hypercalcemia Due to Sarcoidosis by sharing your contact details with the study coordinator.