Acthar on Proteinuria in IgA Nephropathy Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02382523
• Date of registration: 09/01/2015
• Prospective Registration: Yes
• Primary sponsor: Baylor College of Medicine
• Public title: Acthar on Proteinuria in IgA Nephropathy Patients
• Scientific title: Impact of Acthar on Proteinuria and Disease Progression in IgA Nephropathy Patients With Nephrotic Range Proteinuria
• Date of first enrolment: February 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02382523
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: David Sheikh-Hamad, MD
• Affiliation: Baylor College of Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Signed informed consent prior to any study specific procedures

2. Male and females aged 18 years and older

3. BMI 40 kg/m2 or less

4. History of nephrotic syndrome due to IgA (confirmed from renal biopsy performed within
last 5 years)

5. Protein to creatinine (PCR) ratio 2.5 g/g or more (spot urine)

6. 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).

7. 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.

8. 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

9. 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.

10. 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%

Exclusion Criteria:

1. Inability or refusal to give informed consent

2. Unwillingness to receive or intolerant of SC injections of study medication

3. Use of disease modifying agent within "delayed effect" 1 month of Visit 1 with:
glucorticoids, cyclophosphamide, cyclosporine, cellcept

4. 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

5. 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)

6. Planned treatment with live or live attenuated vaccines once enrolled in the study.

7. Contraindication to Acthar per Prescribing Information*

8. For the purpose of this study: history of peptic ulcer is defined as 6 months or less
prior to Visit 1.

9. Renal target disease exclusions*

10. Out of control or severe hypertension

11. History of Systemic Lupus Erythematosus

12. Uncontrolled Type 1 or type 2 diabetes mellitus (prior diagnosis of gestational
diabetes mellitus is not an exclusion)

13. History of Deep Vein Thrombosis (DVT) 6 months or less prior to Visit 1

14. 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

15. 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

16. Chronic active hepatitis C or B infection

17. 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

18. Undergoing or have received therapy for solid tumor malignancy 5 years or less prior
to Visit 1 (with the exception of treated and cured basal cell or treated and cured
squamous cell carcinoma)

19. Undergoing or have received therapy for blood malignancy 5 years or less from Visit 1

20. Cardiovascular:

- History of or active congestive heart failure (NYHA Functional Classification
Class II through IV) on http://sscts.org/ClassificationHeartFailureNYHA.aspx

OR

- History of known dilated cardiomyopathy with left ventricular ejection fraction
30% or less

OR

- Occurrence of any of the following within 3 months of Visit 1:

- Unstable angina

- Myocardial infarction

- Coronary artery bypass graft or percutaneous transluminal coronary
angioplasty

- Transient ischemic attack or cerebrovascular disease; or Unstable arrhythmia

21. Administration of any other investigational medication or participation in an
interventional clinical research study within 30 days of Visit 1

22. Abuse of alcohol or other substance abuse within the 6 months prior to Visit 1 as
determined by the Investigator

23. Subject is a participating Investigator, study coordinator, employee of an
Investigator, or immediate family member of any of the aforementioned



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

IgA Nephropathy

Proteinuria

Intervention(s)

Drug: Acthar 80 unit injection

Primary Outcome(s)

To assess final protein/creatinine ratio [Time Frame: 12 months]

Secondary Outcome(s)

IgA level - change from baseline to 12 months to assess final kidney histology, disease activity index, and disease status. [Time Frame: 12 months]

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]

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]

Albumin - change from baseline to 2 years to assess disease status. [Time Frame: 2 years]

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

Lipid Profile - change from baseline to 2 years to assess disease status. [Time Frame: 2 years]

Serum Creatinine - 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]

Secondary ID(s)

32884 Acthar IgA Nephropathy

Source(s) of Monetary Support

Please refer to primary and secondary sponsors