ACTH Treatment of APOL1- Associated Nephropathy

Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Age Range:21 - Any
Start Date:January 2014
End Date:January 2019

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The purpose of this research study is to determine if the study drug H.C. Acthar gel slows
the progression of your kidney disease. This drug is a steroid-based medicine with fewer side
effects than other steroids used for treatment of kidney diseases similar to APOL1

Inclusion Criteria:

- Non-diabetic African-American with two APOL1-risk genotypes

- Age ≥21 years

- BMI < 40 kg/m2

- Hemoglobin A1c <6.5%

- eGFR ≥30 ml/min/1.73m2

- Historical urine protein: creatinine ratio ≥ 1.0 g/g

- Strong clinical suspicion of APOL1-associated nephropathy or history of biopsy proven
focal segmental glomerulosclerosis (FSGS) or focal global glomerulosclerosis (FGGS)

- Women of childbearing potential: negative serum pregnancy test at Screening and
agreement to follow a medically acceptable form of contraception for the duration of
Acthar administration and 4 weeks thereafter

Exclusion Criteria:

- Diagnosis of diabetes mellitus and/or on pharmacologic treatment for diabetes

- Medical condition that could cause secondary FSGS

- History of sensitivity to steroids (psychosis, steroid-induced diabetes)

- Chronic systemic corticosteroid use (Prednisone or equivalent systemic steroid taken
for more than 4 consecutive weeks within 6 months prior to screening).
Intra-articular, inhaled, and topical steroids are not exclusion criteria.

- Contraindication to Acthar per package insert: scleroderma, osteoporosis, systemic
fungal infections, ocular herpes simplex, recent surgery (within previous 6 months),
history of or the presence of peptic ulcer (within 6 months prior to Screening),
adrenal insufficiency or hyperfunction.

- Acute glaucoma diagnosed ≤3 months prior to Screening

- Biopsy proven glomerular disease other than FSGS or FGGS

- Live or live attenuated vaccine received within 1 month prior to screening, or planned
administration once enrolled in the study

- Uncontrolled hypertension (HTN) (≥ 180/110 mmHg) and frequent admissions (≥1 admission
per 6 months interval) for hypertensive urgency or hypertensive emergency

- Unstable cardiovascular disease: history of congestive heart failure (NYHA Functional
Class III-IV); history of dilated cardiomyopathy with ejection fraction < 40%; any of
the following events within 3 months of screening: unstable angina, myocardial
infarction, coronary artery bypass graft or percutaneous transluminal coronary
angioplasty, transient ischemic attack or cerebrovascular accident, unstable

- Uncontrolled volume overload: history of moderate or severe peripheral edema; on loop
diuretics ≥ 120 mg daily of furosemide or ≥ 3.0 mg daily of bumetanide or ≥ 150 mg
daily of ethacrynic acid or ≥ 60 mg daily of torsemide;

- History of secondary hypertension (i.e., renal artery stenosis, primary aldosteronism
or pheochromocytoma)

- Significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a
life expectancy of less than 1 year

- Subject is expected to initiate dialysis within 6 months

- Previous treatment on a drug being investigated for the treatment of FSGS

- Known diagnosis of Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C

- Known history of a primary immunodeficiency or an underlying condition such as
splenectomy that predisposes the subject to infections

- Systemic hematologic disease (e.g., hematologic malignancy, sickle cell anemia,
myelodysplastic syndrome)

- Current malignancy or history of malignancy within 5 years of screening, with the
exception of non-melanoma skin cancers and cervical intraepithelial neoplasia

- Treatment for any malignancy (e.g., radiation, chemotherapy, hormone therapy, or
biologics) within 5 years of screening, with the exception of locally excised
non-melanoma skin cancer or cervical intraepithelial neoplasia

- Pregnant or breast feeding, or might become pregnant during the study or within 4
weeks after the end of treatment

- Female of reproductive potential not willing to use highly effective methods of birth
control during treatment and for 4 weeks after the end of treatment

- Currently receiving systemic antibiotics for treatment of an active infection; or
history of frequent infections (more than one event per 6 months)

- History of any organ transplant

- Bipolar disorder, or Major Depressive Disorder characterized by severe depression
requiring hospitalization, or history of suicidal ideation/attempts

- Currently enrolled in another interventional study, or less than 4 weeks since ending
another interventional study(s) or receiving investigational agents(s)

- Subject has a disorder that, in the opinion of the investigator, may compromise the
ability of the subject to give written informed consent and/or comply with all
required study procedures.
We found this trial at
Winston-Salem, North Carolina 27157
Winston-Salem, NC
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