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Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes (ACTH)

This study has been completed.
Sponsor:
Information provided by:
Arizona Kidney Disease and Hypertension Center
ClinicalTrials.gov Identifier:
NCT01021540
First received: November 25, 2009
Last updated: July 13, 2011
Last verified: July 2011
History of Changes
  Purpose

To determine if H.P. Acthar Gel (repository corticotrophin) has the same anti-proteinuric effects seen with the synthetic ACTH analogue in Europe.


Condition Intervention Phase
Nephrotic Syndromes
 Drug: Repository corticotrophin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arizona Kidney Disease and Hypertension Center:

Primary Outcome Measures:
  • Acthar has the same anti-proteinuric effects in a wide range of glomerulonephropaties as seen with synthetic ACTH (Synacthen) in Europe [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acthar has similar anti-lipid effects as seen with Synacthen. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Repository corticotrophin
    Acthar 80 IU SQ once a week and titrated up to twice a week
    Other Name: H.P. Acthar Gel
Detailed Description:

Synthetic ACTH (Synacthen Depot) has been used in the treatment of Nephrotic Syndrome in Europe. It has been proven effective in treating idiopathic membranous nephropathy and other various diagnoses involving the kidneys. However, Synacthen is not available in the United States. The only preparation available is the H.P. Acthar Gel (repository corticotrophin) which has been widely used in the treatment of infantile spasms and has been available longer than Synacthen. Therefore, we are conducting this study to determine if H.P. Acthar Gel (repository corticotrophin) is as effective in reducing protein in the urine as seen in synthetic ACTH in Europe.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nephrotic Syndrome with a minimal of 3.5grams of protein per 24 hr period, measured via either 24hr urine collection or spot protein to creatinine ratio.
  • Males and post-menopausal, surgically sterile, or non-lactating and non-pregnant females using adequate contraception
  • Biopsy proven diagnosis of nephrotic syndrome due to Lupus glomerulonephritis, Membranous nephropathy, Focal segmental glomerulosclerosis, Minimal Change disease, Diabetic nephropathy (type 2)or IgA nephropathy.
  • Greater than 18 years of age
  • Willing and able to give informed consent
  • Diabetics are on insulin or willing to start insulin during the study

Exclusion Criteria:

  • Previous intolerance to native ACTH or proteins of porcine origin
  • History of scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, primary adrenocortical insufficiency or adrenocortical hyperfunction.
  • Expected to begin renal replacement therapy or receive a transplant within the next year.
  • Recent cardiovascular event within 3 months of screening including: Myocardial Infarction, CVA, TIA, New York Heart Association Functional Class III or IV failure, Obstructive valvular heart disease, or hypertrophic cardiomyopathy, second or third degree atrioventricular block not successfully treated with a pacemaker.
  • History of HIV
  • Know peptic ulcer disease.
  • SBP> 160 or DBP > 100 at time of enrollment
  • New diagnosis of cancer or recurrent cancer within 2 years of screening
  • History of alcohol or drug abuse within 12 months of study entry.
  • Receipt of any investigational drug within 30 days of enrollment.
  • Anticipated major surgery during trial period
  • Psychiatric disorder that interferes with the patient's ability to comply with the protocol.
  • Inability to cooperate with study personnel or history of noncompliance to medical management
  • Active infection within 1 month of screening
  • Poorly controlled diabetes with an HbA1C > 10%
  • Type 1 diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021540

Locations
United States, Arizona
AKDHC
Phoenix, Arizona, United States, 85032
Sponsors and Collaborators
Arizona Kidney Disease and Hypertension Center
Investigators
Principal Investigator: Sungchun Lee, M.D. Arizona Kidney Disease and Hypertension Center
  More Information

No publications provided

Responsible Party: Sungchun Lee, MD, AKDHC
ClinicalTrials.gov Identifier: NCT01021540     History of Changes
Other Study ID Numbers: 2009003
Study First Received: November 25, 2009
Last Updated: July 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Arizona Kidney Disease and Hypertension Center:
Nephritis,Nephropathy

Additional relevant MeSH terms:
Nephrotic Syndrome
Nephrosis
Kidney Diseases
Urologic Diseases
Adrenocorticotropic Hormone
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013