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

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Sarcoidosis, Hypercalcemia Due to Sarcoidosis

In brief

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

Key facts

Study ID

NCT02155803

Run by

Albany Medical College

People needed

10

Starts

2015-02-01

Expected to finish

2015-11-01

Last updated by the study team

2015-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Albany Medical College — Albany, New York, United States

Full record on ClinicalTrials.gov

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