Acthar on Proteinuria in IgA Nephropathy Patients

Withdrawn before enrolling · Phase 4

Conditions studied: IgA Nephropathy, Proteinuria

In brief

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.

Key facts

Study ID

NCT02382523

Run by

Baylor College of Medicine

People needed

0

Starts

2015-02-01

Expected to finish

2020-01-01

Last updated by the study team

2017-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Subjects must have the following laboratory results for study inclusion:
• Hemoglobin 9 g/dL or more
• Platelets 100 X 10\^3 cells/mu-L
• AST 2x ULN or less
• ALT 2x ULN or less
• Total bilirubin 2x ULN or less
• HgbA1c less than 6.5%

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.
• Renal target disease exclusions*
• Out of control or severe hypertension
• History of Systemic Lupus Erythematosus
• Uncontrolled Type 1 or type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion)
• History of Deep Vein Thrombosis (DVT) 6 months or less prior to Visit 1
• Presence of renal vein thrombosis:
• Known current diagnosis by ultrasound, magnetic resonance imaging (MRI) or computed tomography scan
• Signs or symptoms consistent with occurrence of acute renal vein thrombosis (hematuria in combination with flank pain and >30% unexplained acute rise in serum creatinine) with renal vein thrombosis confirmed by ultrasound, MRI or computed tomography scan
• Reproductive status:
• Women who are pregnant
• Women who are breastfeeding
• Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the Investigator (women who are not of childbearing potential are those that have a history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow for 12 months or more prior to Visit 1
• Chronic active hepatitis C or B infection
• Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation or who are known to be positive for human immunodeficiency virus

Where it is running

• Harris Health System Smith Clinic or Ben Taub Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.