search
Back to results

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

Primary Purpose

Nephrotic Syndromes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Repository corticotrophin
Sponsored by
Arizona Kidney Disease and Hypertension Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrotic Syndromes focused on measuring Nephritis,Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AKDHC

Outcomes

Primary Outcome Measures

Acthar has the same anti-proteinuric effects in a wide range of glomerulonephropaties as seen with synthetic ACTH (Synacthen) in Europe

Secondary Outcome Measures

Acthar has similar anti-lipid effects as seen with Synacthen.

Full Information

First Posted
November 25, 2009
Last Updated
July 13, 2011
Sponsor
Arizona Kidney Disease and Hypertension Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01021540
Brief Title
Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes
Acronym
ACTH
Official Title
Prospective Study Evaluating the Effect of Repository Corticotropin in the Treatment of Various Nephrotic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Arizona Kidney Disease and Hypertension Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndromes
Keywords
Nephritis,Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Repository corticotrophin
Other Intervention Name(s)
H.P. Acthar Gel
Intervention Description
Acthar 80 IU SQ once a week and titrated up to twice a week
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Acthar has similar anti-lipid effects as seen with Synacthen.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sungchun Lee, M.D.
Organizational Affiliation
Arizona Kidney Disease and Hypertension Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKDHC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs