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

• Status: Unknown status
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albany Medical College
• Treatments: Adrenocorticotropic Hormone; beta-Endorphin; Calcium, Dietary; Hormones; Melanocyte-Stimulating Hormones

Criteria

Inclusion Criteria:

1. Age greater than 18 years old.

2. Able to understand English to the point of comprehending the informed consent form.

3. Biopsy proven sarcoidosis.

4. Documented hypercalciuria (urinary excretion of > 4mg/kg of calcium/day) or hypercalcemia within 4 weeks of study entry.

5. 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:

1. A change in anti-sarcoidosis medications within 3 months of study entry.

2. A history of hyperparathyroidism or another non-sarcoidosis cause of hypercalcemia/hypercalciuria

3. A history of Cushing's disease.

4. Have a diagnosis of a medical disorder other than sarcoidosis that in the opinion of the investigator would complicate the evaluation of response treatment.

5. Have used any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.

6. Use of loop or thiazide diuretics for hypertension or other disorders.

7. Chronic use of antacids.