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.

Age range18 Years

SexALL

See this in plain English?

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

✓. 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.

✕. 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.
✕. Use of loop or thiazide diuretics for hypertension or other disorders.
✕. Chronic use of antacids.

Reduction of 24 hour urine calcium

Timeframe: Between week 0 and week 12.

NCT IDNCT02155803

SponsorAlbany Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

Haroon Chaudhry, MBBS