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

NCT02155803 | Unknown Phase 2

• 1 other identifier: AMCMAJCA2014
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sarcoidosis; Hypercalcemia Due to Sarcoidosis

Keywords

Sarcoidosis-Associated Calcium Dysregulation; Sarcoidosis-Associated hypercalciuria; hypercalcemia; hypercalciuria; nephrocalcinosis; nephrolithiasis; interstitial nephritis; glomerulonephritis; acute kidney disease; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Reduction of 24 hour urine calcium

  Reduction of 24 hour urine calcium in patients with sarcoidosis associated hypercalciuria (primary endpoint) between week 0 and week 12.

  Between week 0 and week 12.

Secondary Outcomes (9)

• Change in serum calcium during 12 week ACTHAR GEL treatment

  Baseline compared to 12 weeks.

• Change in 1,25 di-hydroxy Vitamin D during 12 week ACTHAR GEL treatment

  Baseline compared to 12 weeks.

• Change in patient global VAS during 12 week ACTHAR GEL treatment

  Baseline to 12 weeks

• Change in physician global VAS during 12 week ACTHAR GEL treatment

  Baseline to 12 Weeks

• Change in urinary symptoms during 12 week ACTHAR GEL treatment

  Baseline to 12 Weeks

Study Arms (1)

Sarcoidosis related Calcium Dysregulation

EXPERIMENTAL

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.

Drug: ACTHAR Gel (adrenocorticotropic hormone)

Interventions

ACTHAR Gel (adrenocorticotropic hormone) DRUG

ACTHAR GEL (adrenocorticotropic hormone) 80 units subcutaneously twice weekly for 12 weeks

Sarcoidosis related Calcium Dysregulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Sarcoidosis; Hypercalcemia; Hypercalciuria; Nephrocalcinosis; Nephrolithiasis; Nephritis, Interstitial; Glomerulonephritis; Renal Insufficiency, Chronic

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calcinosis; Urolithiasis; Nephritis; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Marc A Judson, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haroon Chaudhry, MBBS

CONTACT

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

Marc A. Judson, MD

CONTACT

518-262-5196; judsonm@mail.amc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marc A. Judson, MD

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 4, 2014
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

US (1)