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

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.

Study Overview

• Status: Unknown
• Conditions: Decrease of Proteinuria With H.P. Acthar Gel and Its Effects on Clinical and Podocyte Function
• Intervention / Treatment: Drug: Acthar

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Milford, Massachusetts, United States, 01757
      • Recruiting
      • Greater Boston Medical Associates 211 West St.
      • Contact: Martin L Gelman, MD; Phone Number: 508-473-2022; Email: gelman85@aol.com
      • Sub-Investigator: Sanja Sever, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients 18-75 with proteinuria as described.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of proteinuria	clinical response and basic science data for podocyte function	2 years

Collaborators and Investigators

• Sponsor: Greater Boston Medical Associates
• Collaborators: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urological Manifestations; Urination Disorders; Proteinuria; Nephrotic Syndrome; Nephrosis
• Other Study ID Numbers: 20150814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Yes if clinically necessary otherwise at end of study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No