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Comparative and Efficacy Study of ACTHar Gel Alone or in Combination With Tacrolimus in Fibrillary Glomerulopathy

NCT04080076 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-09-22

No results posted yet for this study

Summary

Treatment with combination ACTHar gel and Tacrolimus therapy or ACTHar gel therapy alone in lowering urinary protein to creatinine (UP/Cr) ratios

Conditions

  • Renal Disease

Interventions

DRUG

Acthar 80 UNT/ML Injectable Solution

ACTHar 80 Units SQ 1042 x Week

DRUG

Oral Tab Tacrolimus

Oral Tab Tacrolimus (1.0 mg PO BID) in combination with ACTHar 80 Units SQ 2 X week

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • NephroNet, Inc.

    lead OTHER

Principal Investigators

  • James A. Tumlin, MD · NephroNet, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-12
Primary Completion
2024-09-06
Completion
2024-09-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080076 on ClinicalTrials.gov