Clinical Trial: Acthar on Proteinuria in IgA Nephropathy Patients

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Impact of Acthar on Proteinuria and Disease Progression in IgA Nephropathy Patients With Nephrotic Range Proteinuria

Brief 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.


Detailed Summary:

Participation in this study may last up to 2 years (from first visit to final visit) and includes 10 study visits and 8 phone calls.

Subjects will be randomly assigned to one of two treatment groups:

Group A will receive Acthar 80 unit injection 2 times per week or

Group B will receive Acthar 80 unit injection 3 times per week

All participants will be prescribed Lisinopril (10mg per day or higher depending on your blood pressure) as part of regular care for their condition. If they are already on another ACEI, Lisinopril will be prescribed. If subjects are unable to tolerate Lisinopril or other ACEI medications, an angiotensin receptor blocker (ARB) will be prescribed. ARBs are another type of medication that also helps relax blood vessels if subjects cannot tolerate ACEI medications.

Regardless of which treatment group subjects are assigned,everyone will self-inject the study drug using a subcutaneous (SC) injection under the skin using a needle and syringe. Subjects will be trained on the proper technique to be used for each injection before taking study drug home. Enough of the study drug will be given to take home (based on which group the subject is in) to administer until they are seen in 3 months for their next study visit.

Blood samples will be taken for lab tests at each visit and biomarkers (Screening Visit and Visit 9). Women of childbearing potential will also have a pregnancy test done. Approximately 4 teaspoons of blood will be drawn for the Screening Visit and Visit 9.

Subjects must fast at least 8 hours prior to the blood draw.

Same as current

Current Secondary Outcome:

  • Number of Inflammatory cells- change from baseline to 12 months to assess final kidney histology and disease activity index [ Time Frame: 12 months ]
  • Percent of fibrosis (measured by trichrome staining) - change from baseline to 12 months to assess final kidney histology and disease activity index [ Time Frame: 12 months ]
  • IgA level - change from baseline to 12 months to assess final kidney histology, disease activity index, and disease status. [ Time Frame: 12 months ]
  • Amount of sclerosed glomeruli - change from baseline to 12 months to assess final kidney histology and disease activity index [ Time Frame: 12 months ]
  • Serum Creatinine - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  • Albumin - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  • Aldosterone - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  • Cortisol - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  • Lipid Profile - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]
  • P/Cr - change from baseline to 2 years to assess disease status. [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Baylor College of Medicine

Dates:
Date Received: January 9, 2015
Date Started: February 2015
Date Completion: January 2020
Last Updated: April 3, 2017
Last Verified: April 2017