Acthar on Proteinuria in IgA Nephropathy Patients

NCT02382523 | Withdrawn Phase 4 DMC

• 1 other identifier: 32884 Acthar IgA Nephropathy
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy; Proteinuria

Keywords

acthar; proteinuria; IgA nephropathy

Outcome Measures

Primary Outcomes (1)

• To assess final protein/creatinine ratio

  12 months

Secondary Outcomes (10)

• Number of Inflammatory cells- change from baseline to 12 months to assess final kidney histology and disease activity index

  12 months

• Percent of fibrosis (measured by trichrome staining) - change from baseline to 12 months to assess final kidney histology and disease activity index

  12 months

• IgA level - change from baseline to 12 months to assess final kidney histology, disease activity index, and disease status.

  12 months

• Amount of sclerosed glomeruli - change from baseline to 12 months to assess final kidney histology and disease activity index

  12 months

• Serum Creatinine - change from baseline to 2 years to assess disease status.

  2 years

Study Arms (2)

Acthar injection 2 times per week

EXPERIMENTAL

Acthar 80 unit injection 2 times a week

Drug: Acthar 80 unit injection

Acthar injection 3 times per week

EXPERIMENTAL

Acthar 80 unit injection 3 times a week

Drug: Acthar 80 unit injection

Interventions

Acthar 80 unit injection DRUG

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.

Also known as: H.P. Acthar gel

Acthar injection 2 times per week; Acthar injection 3 times per week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to any study specific procedures
• Male and females aged 18 years and older
• BMI 40 kg/m2 or less
• History of nephrotic syndrome due to IgA (confirmed from renal biopsy performed within last 5 years)
• Protein to creatinine (PCR) ratio 2.5 g/g or more (spot urine)
• Estimated GFR (eGFR) greater than 30 mL/min/1.73/m2 (as calculated using the abbreviated Modification of Diet in Renal Disease \[MDRD\] equation as per http://www.kidney.org/professionals/kdoqi/gfr\_calculator.cfm).
• Any prior course of therapy with (but not within the last 3 months): steroids, cyclophosphamide, chlorambucil, cyclosporine or tacrolimus ). If, after f/u period, it was determined that subject did not achieve a complete or partial response, subject will be eligible for this study.
• Antihypertensive treatment including use of Angiotensin-converting enzyme inhibitors (ACEI) and/or Angiotensin receptor blockers (ARB):
• Unless there is a history of intolerance to ACEI or ARB therapy, the subject must be treated with at least one of these agents,
• Treatment with ACEI and/or ARB for 3 months or more prior to Visit 1, with stable maintenance dose(s) for 30 days or more prior to Visit 1,
• If treated with other antihypertensive therapies, treatment duration of 30 days or more and stable maintenance dose for 7 days or more prior to Visit 1; and
• Blood pressure determined by the average of 3 or more seated readings taken 5 minutes or more apart at Visit 1:
• Mean systolic blood pressure 140 mmHg or less and
• Mean diastolic blood pressure 80 mmHg or less.
• Hemoglobin 9 g/dL or more

You may not qualify if:

• Inability or refusal to give informed consent
• Unwillingness to receive or intolerant of SC injections of study medication
• Use of disease modifying agent within "delayed effect" 1 month of Visit 1 with: glucorticoids, cyclophosphamide, cyclosporine, cellcept
• Therapies and/or medications:
• History of previous use of Acthar for treatment of nephrotic syndrome
• Prior sensitivity to Acthar or other porcine protein products
• Planned treatment with live or live attenuated vaccines once enrolled in the study
• Chronic systemic corticosteroid use, defined as any dose of systemic corticosteroid taken for more than 4 consecutive weeks within 1 month prior to Visit 1 (use of topical, inhaled, or intra-articular corticosteroids is allowed)
• Planned treatment with live or live attenuated vaccines once enrolled in the study.
• Contraindication to Acthar per Prescribing Information\*
• For the purpose of this study: history of peptic ulcer is defined as 6 months or less prior to Visit 1.
• Out of control or severe hypertension
• History of Systemic Lupus Erythematosus
• History of Deep Vein Thrombosis (DVT) 6 months or less prior to Visit 1
• Presence of renal vein thrombosis:

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Harris Health System Smith Clinic or Ben Taub Hospital

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Sheikh-Hamad, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Medicine-Nephrology)

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: March 6, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: April 5, 2017

Record last verified: 2017-04

Locations

US (1)