Bardoxolone methyl for Chronic Kidney Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Kidney Disease+2 MoreBardoxolone methyl - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the long-term safety and tolerability of an experimental drug, bardoxolone methyl, in patients with chronic kidney disease who have previously taken the drug in another trial. The trial will end when the drug is commercially available or when patients withdraw from the trial.

Eligible Conditions
  • Chronic Kidney Disease
  • Alport Syndrome
  • Polycystic Kidney Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to 5 years

Up to 5 years
Long-term safety: by incidence of adverse events and serious adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg
15%Muscle spasms
14%Nausea
14%Upper respiratory tract infection
14%Diarrhoea
11%Headache
11%Dyspnoea
9%Fatigue
9%Nasopharyngitis
9%Decreased appetite
7%Gastrooesophageal reflux disease
7%Urinary tract infection
7%Alanine aminotransferase increased
5%Abdominal pain
5%Sinusitis
5%Aspartate aminotransferase increased
5%Back pain
5%Dizziness
5%Cough
4%Constipation
4%Non-cardiac chest pain
4%Oedema peripheral
4%Contusion
4%Brain natriuretic peptide increased
4%Gamma-glutamyltransferase increased
4%Weight decreased
4%Arthralgia
4%Oropharyngeal pain
3%Epistaxis
3%Dyspnoea exertional
3%Dry mouth
3%Palpitations
3%Vomiting
3%Pyrexia
3%Bronchitis
3%Herpes zoster
3%Tooth abscess
3%Liver function test abnormal
3%N-terminal prohormone brain natriuretic peptide increased
3%Pain in extremity
3%Dysgeusia
3%Anxiety
3%Rales
3%Increased tendency to bruise
3%Pruritus
3%Hypertension
3%Sinus congestion
3%Tachycardia
3%Gastroenteritis
1%Pulmonary arterial hypertension
1%Atrial fibrillation
1%Ventricular arrhythmia
1%Cellulitis
1%Basal cell carcinoma
1%Thrombocytopenia
1%Vertigo
1%Abdominal distension
1%Pain
1%Drug hypersensitivity
1%Rhinitis
1%Serum ferritin decreased
1%Fluid retention
1%Glucose tolerance impaired
1%Myalgia
1%Neck pain
1%Dizziness exertional
1%Presyncope
1%Syncope
1%Depression
1%Dysuria
1%Breast mass
1%Vaginal haemorrhage
1%Pleural effusion
1%Upper-airway cough syndrome
1%Alopecia
1%Rash papular
1%Cardiac discomfort
1%Flatulence
1%Dyspepsia
1%Insomnia
1%Hypoxia
1%Anaemia
1%Toothache
1%Conjunctivitis infective
1%Influenza
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02036970) in the Part 1 Period of Part 1: Dose Titration: Bardoxolone Methyl 10 mg/Part 2: Bardoxolone Methyl 10 mg ARM group. Side effects include: Muscle spasms with 15%, Nausea with 14%, Upper respiratory tract infection with 14%, Diarrhoea with 14%, Headache with 11%.

Trial Design

1 Treatment Group

Bardoxolone methyl
1 of 1

Experimental Treatment

480 Total Participants · 1 Treatment Group

Primary Treatment: Bardoxolone methyl · No Placebo Group · Phase 3

Bardoxolone methyl
Drug
Experimental Group · 1 Intervention: Bardoxolone methyl · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bardoxolone methyl
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Reata Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
6,356 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who else is applying?

What state do they live in?
Massachusetts33.3%
Arizona33.3%
Texas33.3%
How old are they?
65+33.3%
18 - 6566.7%
What site did they apply to?
Arizona Kidney Disease and Hypertension Research Services, PLLC50.0%
Tufts Medical Center - Division of Nephrology50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria33.3%
Met criteria66.7%