Recruiting

Acthar

Sponsor:

Greater Boston Medical Associates

Code:

NCT03644771

Conditions

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Acthar

Study Details

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

Study ID

NCT03644771

Start date

Jan 25, 2017

Status verified date

Feb, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • level of proteinuria [ Time Frame: 2 years ]

Central Contacts and Locations

Locations

Greater Boston Medical Associates 211 West St.

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

Martin L Gelman, MD

508-473-2022gelman85@aol.com

More Information

Sponsor

Greater Boston Medical Associates

Last update posted

Feb 5, 2020

Last verified

Feb, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Greater Boston Medical Associates on 2020-02-05.