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Corticosteroid

ACTH-32 units for Nephrotic Syndrome (ACTH-NRDN Trial)

Phase 4
Waitlist Available
Led By James A. Tumlin, MD
Research Sponsored by Southeast Renal Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions
Pivotal Trial
Drug Has Already Been Approved

Summary

This is a prospective open labeled trial examining the efficacy of ACTHar Gel (porcine ACTH) on the level of proteinuria in patients with diabetic nephropathy and nephrotic range proteinuria.

Eligible Conditions
  • Nephrotic Syndrome
  • Diabetic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: ACTH-32 unitsActive Control1 Intervention
Patients with nephrotic range proteinuria randomized to this group will receive 32 units ACTHargel sub-cutaneously every day.
Group II: ACTH-16 unitsActive Control1 Intervention
Patients with nephrotic range proteinuria randomized to this group will receive 16 units ACTHargel sub-cutaneously every day.

Find a Location

Who is running the clinical trial?

Southeast Renal Research InstituteLead Sponsor
6 Previous Clinical Trials
83 Total Patients Enrolled
1 Trials studying Nephrotic Syndrome
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,851 Total Patients Enrolled
4 Trials studying Nephrotic Syndrome
106 Patients Enrolled for Nephrotic Syndrome
James A. Tumlin, MDPrincipal InvestigatorSoutheast Renal Research Institute
2 Previous Clinical Trials
~1 spots leftby Oct 2025
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