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

NCT ID: NCT03644771

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-25
• Study Completion Date: 2021-12-31

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.

Detailed Description

Patients with proteinuria/nephrotic syndrome with albumin/creatinine ratios of 50 or 24 hour urine protein of 500mg or greater will receive increasing doses of H.P. Acthar Gel starting with 20 units weekly or biweekly for 3 months after a one month washout observational period.

The second three month period calls for 40 units biweekly, and the third three month period uses 80 units biweekly observing if the reduction in proteinuria reaches a goal of 50-100%.

Pre study clinical parameters include Cbc diff, cmp, lipid with ldl, cortisol, acth, 24 hour urine for creatinine and protein, urine albumin/creatinine ratio, protein/creatinine ratio, bone density, hgba1c, weight , blood pressure, vital signs, and overall health questionaire. Monthly cbc, cmp, prot/creat, alb/creat ratios, and one red top tube and one 50cc urine container to go to MGH Charlestown for basic podocyte studies. The fourth -3 month observational period will be with tapering to stopping the dose of Acthar and following the same monthly and the pre study parameters.

A second year of observation will continue checking patients every other month for one year to determine the length of protein decrement observed in the first year.

The study will conclude after the second year of drug free followup.

Biomarker studies of podocyte function will be done for the full 2 year period.

Final data analysis will conclude after the 2 year period of observation.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Acthar

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Greater Boston Medical Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Greater Boston Medical Associates 211 West St.

Milford, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Martin L Gelman, MD

Role: primary

gelman85@aol.com

508-473-2022

Other Identifiers

20150814

Identifier Type: -

Identifier Source: org_study_id