A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

For patients with autosomal dominant polycystic kidney disease (ADPKD) enrolled in this study, the objectives to assess bardoxolone methyl relative to placebo are as follows:

Primary:

- To assess the change from baseline in estimated glomerular filtration rate (eGFR) at Week 52 following a 4-week drug treatment withdrawal period.

- To assess safety and tolerability.

Key Secondary:

- To assess the change from baseline in eGFR at Week 104 following a 4-week drug treatment withdrawal period.

 

Description

    - 100 week long study, 20 visit to the clinic in the 100 weeks. - There will be Phone calls. - Need to document weight daily and you will be give a scale. - Lab work done during the study. - ECG, Echo Cardiogram.

Details
Condition Kidney Disease
Clinical Study IdentifierTX227890
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Kidney Disease?
Male and female patients 18 ≤ age ≤ 70 upon study consent
Diagnosis of ADPKD by modified Pei-Ravine criteria
) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI
with family history of ADPKD or
) at least 10 cysts per kidney by any radiologic method and exclusion of
other cystic kidney diseases if without family history
Screening eGFR (average of Screen A and Screen B eGFR values) ≥ 30 to ≤
mL/min/1.73 m2 (18 to 55 years) or ≥ 30 to ≤ 44 mL/min/1.73 m2 (56 to 70
years)
a. Patients with either screening eGFR ≥ 60 to ≤ 90 mL/min/1.73 m2 or age 56
to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of ≥
0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor
discretion)
b. The two eGFR values collected at Screen A and Screen B visits used to
determine eligibility must have a percent difference ≤ 25%
Albumin to creatinine ratio (ACR) ≤ 2500 mg/g at Screen B visit
Systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 80
mmHg at Screen A visit after a period of rest. Patients receiving an
angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II
receptor blocker (ARB) must be on a stable dose for at least 6 weeks prior to
the Screen A visit
Adequate bone marrow reserve and organ function at the Screen A visit
as follows
a. Hematologic: Absolute neutrophil count > 1.5 x 109 /L, platelets > 100 x
L, hemoglobin (Hgb) ≥ 9 g/dL
b. Hepatic: Total bilirubin (TBL), alanine aminotransferase (ALT), and
aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)
Able to swallow capsules
Willing and able to comply with scheduled visits, treatment plan
laboratory tests, and other study procedures
Evidence of a personally signed and dated informed consent document
indicating that the patient has been informed of all pertinent aspects of the
study prior to initiation of any protocol-mandated procedures

Exclusion Criteria

Prior exposure to bardoxolone methyl
Patients previously treated with tolvaptan must have discontinued drug
for at least 3 months prior to Screen A
History of administration of polycystic kidney disease-modifying agents
(somatostatin analogues) within 3 months prior to the Screen A visit
B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit
Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit
Serum albumin < 3 g/dL at Screen A visit
History of intracranial aneurysms
Kidney or any other solid organ transplant recipient or a planned
transplant during the study
Acute dialysis or acute kidney injury within 12 weeks prior to Screen A
visit or during Screening
History of clinically significant left-sided heart disease and/or
clinically significant cardiac disease, including but not limited to any of
the following
a. Clinically significant congenital or acquired valvular disease
b. Left ventricular ejection fraction < 40% (based on echocardiogram performed
at Screen A visit or within 6 months prior to Day 1)
c. Pericardial constriction (based on echocardiogram performed at Screen A
visit or within 6 months prior to Day 1)
d. Restrictive or congestive cardiomyopathy (based on echocardiogram performed
at Screen A visit or within 6 months prior to Day 1)
e. Symptomatic coronary disease (prior myocardial infarction, percutaneous
coronary intervention, coronary artery bypass graft surgery, or angina)
f. History of hospitalization for heart failure
g. Cardiac insufficiency, defined as New York Heart Association Class III or
IV
h. History of untreated atrial fibrillation
i. History of unstable arrhythmias
Systolic BP < 90 mm Hg at Screen A visit after a period of rest
BMI < 18.5 kg/m2 at the Screen A visit
History of malignancy within 5 years prior to Screen A visit, with the
exception of localized skin or cervical carcinomas
Systemic immunosuppression for more than 2 weeks, cumulatively, within
the 12 weeks prior to randomization or anticipated need for immunosuppression
during the study
Untreated or uncontrolled active bacterial, fungal, or viral
infection
Participation in other interventional clinical studies within 30 days
prior to Day 1
Unwilling to practice acceptable methods of birth control (both males
who have partners of child-bearing potential and females of childbearing
potential) during Screening, while taking study drug, and for at least 30 days
after the last dose of study drug is ingested
Women who are pregnant or breastfeeding
Known hypersensitivity to any component of the study drug
Any abnormal laboratory level that, in the opinion of the
investigator, would put the patient at risk by trial enrollment
Patient is, in the opinion of the investigator, unable to comply with
the requirements of the study protocol or is unsuitable for the study for any
reason
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