UnknownPhase 2/3

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

United States10 participantsStarted 2015-02

Plain-language summary

ACTHAR Gel has activity in sarcoidosis associated hypercalciuria and calcium dysregulation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. A change in anti-sarcoidosis medications within 3 months of study entry.
. A history of hyperparathyroidism or another non-sarcoidosis cause of hypercalcemia/hypercalciuria
. A history of Cushing's disease.
. Have a diagnosis of a medical disorder other than sarcoidosis that in the opinion of the investigator would complicate the evaluation of response treatment.
. Have used any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction of 24 hour urine calcium

Timeframe: Between week 0 and week 12.

Trial details

NCT IDNCT02155803

SponsorAlbany Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

Contact for this trial

Haroon Chaudhry, MBBS

518-262-1542 chaudhh@mail.amc.edu

View on ClinicalTrials.gov More Sarcoidosis trials