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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH

NCTNCT01155141 (opens ClinicalTrials.gov in a new tab)Other idSU-08182009-3600
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures ACTH (corticotropin), does not give it. It appears in the eligibility rules.

Overview

Status
Completed
Phase
Phase 4
Enrollment
15 participants (actual)
Sponsor
Stanford University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Sept 2009
Primary completion
Jan 2014
Completion
Jan 2014
First posted
1 Jul 2010 (estimated)
Last update posted
1 Sept 2014 (estimated)
Conditions
Kidney Diseases

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012201320142015
  1. Ph 4

    Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH

    NCT01155141

    Sept 2009 to Jan 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • H.P. Acthar GelDrug

Arms1

  • Experimental

    No arms

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

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 24 Hour Proteinuria

    Time frame · Baseline - Month 6

  2. Serum Creatinine

    Time frame · Baseline - Month 6

  3. Protein/Creatinine Ratio

    Time frame · Baseline - Month 6

Secondary outcomes(6)

  1. eGFR

    Time frame · Baseline - Month 6

  2. Weight

    Time frame · Baseline - Month 6

  3. Systolic Blood Pressure

    Time frame · Baseline - Month 6

  4. Diastolic Blood Pressure

    Time frame · Baseline - Month 6

  5. Glucose

    Time frame · Baseline - Month 6

  6. Total Cholesterol

    Time frame · Baseline - Month 6

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Baseline - Month 6

24 Hour Proteinuria

GroupValue (g/day)Spread
H.P. Acthar Gel3.65.7
Primary outcomeMedian· Baseline - Month 6

Serum Creatinine

GroupValue (mg/dL)Spread
H.P. Acthar Gel1.40.9
Primary outcomeMedian· Baseline - Month 6

Protein/Creatinine Ratio

GroupValue (unitless)Spread
H.P. Acthar Gel3.12.3
Secondary and other outcome results(5)
Secondary outcomeMedian· Baseline - Month 6

eGFR

GroupValue (mL/min/1.73m^2)Spread
H.P. Acthar Gel56.034.8
Secondary outcomeMedian· Baseline - Month 6

Weight

GroupValue (kg)Spread
H.P. Acthar Gel87.524.3
Secondary outcomeMedian· Baseline - Month 6

Systolic Blood Pressure

GroupValue (mm Hg)Spread
H.P. Acthar Gel128.015.9
Secondary outcomeMedian· Baseline - Month 6

Diastolic Blood Pressure

GroupValue (mm Hg)Spread
H.P. Acthar Gel82.09.8
Secondary outcomeMedian· Baseline - Month 6

Glucose

GroupValue (mg/dL)Spread
H.P. Acthar Gel958.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
H.P. Acthar GelPatients 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.–2 / 1513 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2013

Treatment of idiopathic FSGS with adrenocorticotropic hormone gel.

Hogan et al. 2013Clinical journal of the American Society of Nephrology : CJASNcited by 68

PMID 24009220PMC3848392DOI 10.2215/cjn.02840313PUB-24009220

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 16 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 1\. Biopsy proven FSGS * 2\. Ability to consent and complete study evaluations * 3\. Greater than 2g/day of proteinuria * 4\. No contraindications to treatment with corticosteroids or ACTH * 5\. Women of childbearing potential will agree to use effective forms of birth control throughout this study Exclusion Criteria: * 1\. Known secondary cause of FSGS * 2\. Receiving active immune therapy (within 90 days) * 3\. Pregnancy * 4\. Creatinine \>2.5 mg/dl * 5\. Uncontrolled HTN (\>180/100mm Hg) * 6\. Diabetes * 7\. Acute or chronic infection * 8\. Severe comorbidity (active coronary, cerebrovascular disease, cancer, psychiatric disease) * 9\. Age \< 16, \>65 years * 10\. Evidence of untreated tuberculosis (+PPD or Ellispot Gold testing) * 11\. 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.

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