MedTrace Logo

Acthar on Proteinuria in IgA Nephropathy Patients

NCT02382523 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-04-05

No results posted yet for this study

Summary

IgA nephropathy occurs when IgA-a protein that helps the body fight infections-settles in the kidneys. IgA deposits may cause the kidneys to leak blood and sometimes protein in the urine. Proteinuria (abnormal amounts of protein in urine) can be a sign of kidney damage. Current treatments for IgA nephropathy is limited to Angiotensin Converting Enzyme (ACE) inhibitor medications with fish oil. ACE Inhibitors, also called ACEI medications, slows the angiotensin converting enzyme so that blood vessels can be relaxed.

This study involves the study drugs, Acthar and Lisinopril (an ACEI medication routinely given for high blood pressure).

In previous clinical studies, some subjects with IgA nephropathy have experienced reductions in proteinuria with consistent use of Acthar. Acthar is approved by the Food and Drug Administration (FDA) and used to treat patients with proteinuria.

The purpose is to study the safety and effectiveness of the study drug Acthar given at different doses.

Conditions

Interventions

DRUG

Acthar 80 unit injection

Subjects not responding after 3 months of therapy (increasing creatinine; proteinuria not lower by 30%), will continue therapy at a dose 120 U SC x2/wk. Treatment will be discontinued if improvement is not observed 6 months after initiation of therapy. If partial remission is achieved with Acthar 80 U SC x2/wk or x3/wk then Acthar will be increased to 120 U SCx2/wk; if remission is achieved, treatment will be continued at this dose for a total of 12 months; otherwise, if response is not observed after 3 months of treatment with the higher dose, we will resume therapy with the original dose/schedule. We will check anti-ACTH antibodies in non-responders. If relapse occurs during the follow-up period, a 6 month treatment with Acthar at 120 U SC x2/wk will be started (not for partial responders), and the response will be assessed.

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • David Sheikh-Hamad, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2019-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02382523 on ClinicalTrials.gov