Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03644771
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Greater Boston Medical Associates

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.


Condition or disease Intervention/treatment
Decrease of Proteinuria With H.P. Acthar Gel and Its Effects on Clinical and Podocyte Function 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: 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 Measures :
  1. level of proteinuria [ Time Frame: 2 years ]
    clinical response and basic science data for podocyte function


Biospecimen Retention:   Samples Without DNA
one red top tube of blood per month one 50cc urine container per month


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients 18-75 with proteinuria as described.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644771


Locations
Layout table for location information
United States, Massachusetts
Greater Boston Medical Associates 211 West St. Recruiting
Milford, Massachusetts, United States, 01757
Contact: Martin L Gelman, MD    508-473-2022    gelman85@aol.com   
Sub-Investigator: Sanja Sever, PhD         
Sponsors and Collaborators
Greater Boston Medical Associates
Massachusetts General Hospital
Layout table for additonal information
Responsible Party: Greater Boston Medical Associates
ClinicalTrials.gov Identifier: NCT03644771    
Other Study ID Numbers: 20150814
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Yes if clinically necessary otherwise at end of study

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Proteinuria
Nephrotic Syndrome
Nephrosis
Urination Disorders
Urologic Diseases
Urological Manifestations
Kidney Diseases