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Kidney DiseaseNCT02006849

ACTH Treatment of APOL1- Associated Nephropathy

A study testing Acthar in people with Kidney Disease, run by Wake Forest University Health Sciences at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Kidney Disease
What is being tested?
Acthar
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2014to Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 27Show fewer
  • 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
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Conditions
Kidney Disease
Being tested
Acthar
Keywords
AfricanAmericans, Hypertension, Proteinuria, ApoL1 gene
Medical subject headings
Kidney Diseases, Hypertension, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActharDrug

    Also called Repository Corticotropin

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

Study groups in NCT02006849
Study groupRoleWhat they receive
Acthar 40 unitsOtherActhar 40 units subcutaneously three times a week for patients with sub-nephrotic proteinuria.
Receives: Drug: Acthar
Acthar 80 unitsOtherActhar 80 units subcutaneously twice a week for patients with nephrotic proteinuria.
Receives: Drug: Acthar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

  3. 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

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

Secondary outcomes (6)

  1. Percent change in proteinuria

    Percent change in proteinuria after 1 year and 2 years of follow-up

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

  2. Percent change in CKD-EPI eGFR

    Percent change in CKD-EPI eGFR at 1 and 2 years of study follow-up

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

  3. Change in CKD-EPI eGFR

    Change in eGFR over time, based on baseline proteinuria (nephrotic vs. sub-nephrotic), baseline eGFR (eGFR 30-45 vs. eGFR 45-59), and Acthar dose

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

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

    Proportion of patients with baseline nephrotic proteinuria who sustained CR or PR at 1 and 2 years of study follow-up

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

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

    Modifications in kidney histopathology on second post-treatment kidney biopsy (% glomerulosclerosis, % tubulointerstitial fibrosis, restoration of podocyte markers [e.g.,podocin, synaptopodin, Wilms tumor 1]) compared with baseline biopsy

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

  6. Cholesterol and lipoprotein profile before and after treatment with H.C. Acthar gel

    Changes in cholesterol and lipoprotein levels compared with baseline profiles

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2019 (estimated)

Why it stopped: no enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02006849
Sponsor's protocol ID
IRB00024943
Status last verified
Apr 2016
First submitted
4 Dec 2013
Last updated
7 Nov 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Acthar in people with Kidney Disease, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in proteinuria with H.C. Acthar gel (time frame: End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02006849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.

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