NCT01155141

Brief Summary

FSGS is an immunologic disorder wherein circulating immune proteins cause damage to the kidneys and progressive injury and scarring. Corticosteroid therapy is occasionally, but not nearly universally, successful in reducing proteinuria, and when patients respond, they have a favorable prognosis. The investigators believe that ACTH therapy (H.P. Acthar Gel) can provide a more rapid, well tolerated reduction in glomerular injury.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

4.3 years

First QC Date

June 29, 2010

Results QC Date

August 1, 2014

Last Update Submit

August 20, 2014

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (3)

  • 24 Hour Proteinuria

    Baseline - Month 6

  • Serum Creatinine

    Baseline - Month 6

  • Protein/Creatinine Ratio

    Baseline - Month 6

Secondary Outcomes (6)

  • eGFR

    Baseline - Month 6

  • Weight

    Baseline - Month 6

  • Systolic Blood Pressure

    Baseline - Month 6

  • Diastolic Blood Pressure

    Baseline - Month 6

  • Glucose

    Baseline - Month 6

  • +1 more secondary outcomes

Study Arms (1)

No arms

EXPERIMENTAL

There are no arms to this study. All patients receive drug (H.P. Acthar Gel)

Drug: H.P. Acthar Gel

Interventions

H.P. Acthar GelDRUG

Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.

No arms

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Biopsy proven FSGS
  • \. Ability to consent and complete study evaluations
  • \. Greater than 2g/day of proteinuria
  • \. No contraindications to treatment with corticosteroids or ACTH
  • \. Women of childbearing potential will agree to use effective forms of birth control throughout this study

You may not qualify if:

  • \. Known secondary cause of FSGS
  • \. Receiving active immune therapy (within 90 days)
  • \. Pregnancy
  • \. Creatinine \>2.5 mg/dl
  • \. Uncontrolled HTN (\>180/100mm Hg)
  • \. Diabetes
  • \. Acute or chronic infection
  • \. Severe comorbidity (active coronary, cerebrovascular disease, cancer, psychiatric disease)
  • \. Age \< 16, \>65 years
  • \. Evidence of untreated tuberculosis (+PPD or Ellispot Gold testing)
  • \. A known contraindication to ACTH. Corticotropin is considered contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Hogan J, Bomback AS, Mehta K, Canetta PA, Rao MK, Appel GB, Radhakrishnan J, Lafayette RA. Treatment of idiopathic FSGS with adrenocorticotropic hormone gel. Clin J Am Soc Nephrol. 2013 Dec;8(12):2072-81. doi: 10.2215/CJN.02840313. Epub 2013 Sep 5.

    PMID: 24009220DERIVED

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. Richard Lafayette
Organization
Stanford University
czar@stanford.edu
650-498-6063

Study Officials

  • Richard Lafayette

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2010

First Posted

July 1, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 1, 2014

Results First Posted

September 1, 2014

Record last verified: 2014-08

Locations

US(1)