NCT02006849

Brief Summary

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 nephropathy.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 7, 2017

Status Verified

April 1, 2016

Enrollment Period

5 years

First QC Date

December 4, 2013

Last Update Submit

November 3, 2017

Conditions

Kidney Disease

Keywords

AfricanAmericansHypertensionProteinuriaApoL1 gene

Outcome Measures

Primary Outcomes (3)

  • Change in proteinuria with H.C. Acthar gel

    Complete remission (CR) (UPCR \<0.2g/g) or partial remission (PR) (50% drop in UPCR from baseline) of proteinuria at the end of Treatment period in patients with baseline nephrotic proteinuria

    End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)

  • Change in proteinuria with H.C. Acthar gel

    Percent change in proteinuria at the end of Treatment period in patients with baseline sub-nephrotic proteinuria

    End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)

  • Change in eGFR with H.C. Acthar gel

    Percent change in Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR at the end of Treatment period

    End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)

Secondary Outcomes (6)

  • Percent change in proteinuria

    1 year and 2 years of study follow-up after treatment completion

  • Percent change in CKD-EPI eGFR

    1 year and 2 years of study follow-up after treatment completion

  • Change in CKD-EPI eGFR

    1 year and 2 years of study follow-up after treatment completion

  • Duration of remission after H.C. Acthar gel treatment

    1 year and 2 years of study follow-up after treatment completion

  • Changes in kidney fibrosis after H.C. Acthar gel treatment

    End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)

  • +1 more secondary outcomes

Study Arms (2)

Acthar 40 units

OTHER

Acthar 40 units subcutaneously three times a week for patients with sub-nephrotic proteinuria.

Drug: Acthar

Acthar 80 units

OTHER

Acthar 80 units subcutaneously twice a week for patients with nephrotic proteinuria.

Drug: Acthar

Interventions

ActharDRUG

FDA approved drug being used in this study for sub-nephrotic proteinuria. Given Investigational New Drug (IND) exemption by FDA.

Also known as: Repository Corticotropin
Acthar 40 unitsActhar 80 units

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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 arrhythmia
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Kidney DiseasesHypertensionProteinuria

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Mariana Murea, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 10, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 7, 2017

Record last verified: 2016-04

Locations

US(1)