Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function

NCT03644771 | Unknown

• 1 other identifier: 20150814
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with proteinuria to start treatment with Acthar and watch a variety of clinical parameters with a goal of decreasing proteinuria between 50-100% over a period of nine months with every 3 months increasing the dose of medication until a decrease of either 50- 100 % of protein excretion is achieved. In addition addition podocyte function will be assessed monthly by measuring suPar levels, tnf alpha, podocyte/creatinine levels as well as podocyte function studies.

Conditions

Decrease of Proteinuria With H.P. Acthar Gel and Its Effects on Clinical and Podocyte Function

Outcome Measures

Primary Outcomes (1)

• level of proteinuria

  clinical response and basic science data for podocyte function

  2 years

Interventions

Acthar DRUG

4 treatment periods of 3 months each with 20 units biweekly, 40 units biweekly, and 80 units biweekly, with a tapering period to no drug for the fourth 3 month period. Then one year f/u.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients 18-75 with proteinuria as described.

You may qualify if:

• patients with proteinuria as above. patients with controlled conditions below are candidates.

You may not qualify if:

• uncontrolled hypertension,diabetes mellitus, congestive heart failure, coronary artery disease, peripheral vascular disease.

Sponsors & Collaborators

• Greater Boston Medical Associates: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Greater Boston Medical Associates 211 West St.

Milford, Massachusetts, 01757, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

one red top tube of blood per month one 50cc urine container per month

MeSH Terms

Interventions

Adrenocorticotropic Hormone

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 23, 2018
• Study Start: January 25, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)