Clinical trials: Rta
Friedreich Ataxia
A Study to Learn About the Effects and Safety of RTA 408 (Omaveloxolone) in People Aged 16 to 40 With Friedreich's Ataxia
In this study, researchers are learning more about RTA 408, also known as omaveloxolone, BIIB141, or SKYCLARYS®. The main goal of this study is to learn more about the safety of RTA 408 and how it affects physical effort…
- Trial name
- NCT02255435
- Testing
- Omaveloxolone Capsules, 2.5 mg, Omaveloxolone Capsules, 5 mg, Omaveloxolone Capsules, 10 mg
- Where
- 11 sites in United States, Australia and 3 more
- Volunteers
- 172 people
- Sponsor
- Biogen
Advanced Solid Tumors, Lymphoid Malignancies
RTA 402 in Patients With Advanced Solid Tumors or Lymphoid Malignancies
This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.
- Trial name
- NCT00529438
- Testing
- Bardoxolone methyl
- Where
- 3 sites in United States
- Volunteers
- 47 people
- Sponsor
- Biogen
Diabetic Kidney Disease
A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study
The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in…
- Trial name
- NCT03550443
- Testing
- Bardoxolone methyl
- Where
- Japan
- Volunteers
- 1,323 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the…
- Trial name
- NCT02657356
- Testing
- Bardoxolone methyl capsules
- Where
- 106 sites in United States, Argentina and 13 more
- Volunteers
- 202 people
- Sponsor
- Biogen
Chronic Kidney Diseases
A Trial of Bardoxolone Methyl in Patients With CKD at Risk of Rapid Progression (MERLIN)
This multi-center, randomized, double-blind, placebo-controlled, Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with CKD due to multiple etiologies at risk of rapid…
- Trial name
- MERLIN (NCT04702997)
- Testing
- Bardoxolone methyl oral capsule
- Where
- 12 sites in United States
- Volunteers
- 81 people
- Sponsor
- Biogen
Cognitive Assessment
Remote Testing in Abbiategrasso (RTA)
The remote cognitive assessment has the advantage of reaching people despite the restrictions due to the pandemic, so it is of fundamental importance both in the treatment of dementia and the research context.
- Trial name
- RTA (NCT05135806)
- Where
- Italy
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Fondazione Golgi Cenci
Inflammation and Pain Following Ocular Surgery
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic Suspension in the treatment of patients who have inflammation and pain following ocular surgery.
- Trial name
- NCT02065375
- Testing
- Omaveloxolone Ophthalmic Suspension 1.0%, Omaveloxolone Opthalmic Suspension 0.5%
- Where
- 6 sites in United States
- Volunteers
- 109 people
- Sponsor
- Biogen
IgA Nephropathy, CKD Associated With Type 1 Diabetes
A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases - PHOENIX
This multi-center, open-label Phase 2 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with the following rare chronic kidney diseases (CKD): CKD associated with type 1 diabetes…
- Conditions
- IgA Nephropathy, CKD Associated With Type 1 Diabetes, Focal Segmental Glomerulosclerosis, Autosomal Dominant Polycystic Kidney
- Trial name
- PHOENIX (NCT03366337)
- Testing
- Bardoxolone methyl capsules
- Where
- 30 sites in United States
- Volunteers
- 103 people
- Sponsor
- Biogen
Chronic Kidney Disease, Type 2 Diabetes
The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when this compound is administered once daily for…
- Trial name
- NCT02316821
- Testing
- RTA 402
- Where
- Japan
- Volunteers
- 216 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Trauma, Road (Traffic) Accident [RTA] Nos
Pre-hospital Care Profile of Road Traffic Injury Victims- Kerala
Selection of appropriate strategies and correct policy-making in these conditions may lead to decreased rates of death due to RTI.There is a lack of research on the effectiveness of pre-hospital care in Kerala.
- Trial name
- PCP-K (NCT04577924)
- Testing
- Interview
- Where
- India
- Volunteers
- 978 people, healthy volunteers welcome
- Sponsor
- Jubilee Mission Medical College and Research Institute
Epidemiology, Road (Traffic) Accident [RTA] Nos
Epidemiology of Road Traffic Accidents in Riyadh Region in the Last Five Years (2019-2023)
The findings arising from the proposed study will spot light on the issue of road traffic accidents in Riyadh Region which will help stakeholders to design proper plans and strategies of prevention and control of this issue.
- Conditions
- Epidemiology, Road (Traffic) Accident [RTA] Nos, Riyadh
- Trial name
- NCT06553586
- Testing
- Data collection
- Where
- Egypt
- Volunteers
- 500 people
- Sponsor
- Assiut University
Chronic Kidney Disease, Type 2 Diabetes
Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease
This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2 diabetes and chronic kidney disease.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes, Diabetic Nephropathy
- Trial name
- NCT00811889
- Testing
- Bardoxolone Methyl (RTA 402)
- Where
- 42 sites in United States
- Volunteers
- 227 people
- Sponsor
- Biogen
Obese Adult Male
A Study of RTA 402 in Obese Adults
To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.
- Trial name
- NCT04018339
- Testing
- Bardoxolone methyl
- Where
- Japan
- Volunteers
- 22 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Healthy Subject
A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults
Food effect part: To investigate the effect of food on the pharmacokinetics of RTA 402 and evaluate the safety of RTA 402 in Japanese healthy male adults, using the capsule formulations.
- Trial name
- NCT04023903
- Testing
- Bardoxolone methyl
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Corneal Endothelial Cell Loss, Ocular Pain
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
- Conditions
- Corneal Endothelial Cell Loss, Ocular Pain, Ocular Inflammation, Cataract Surgery
- Trial name
- NCT02128113
- Testing
- Vehicle Ophthalmic Solution, Omaveloxolone Ophthalmic Suspension 0.5%, Omaveloxolone Ophthalmic Suspension 1%
- Where
- 15 sites in United States
- Volunteers
- 307 people
- Sponsor
- Biogen
Cow's Milk Protein Allergy, Rta
Association of Renal-tubular Acidosis in Children With Cow Milk Protein Allergy
Our study aims to detect renal manifestations of children proved to be with cow milk protein allergy special focusing on tubular dysfunction.
- Trial name
- NCT06494852
- Testing
- investigations
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Sohag University
Glioma
A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas
This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.
- Trial name
- NCT00526812
- Testing
- RTA 744, RTA 744 injection
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- Biogen
Friedreich Ataxia
A Study to Find Out How BIIB141 (Omaveloxolone) is Processed in the Body and to Learn More About Its Safety in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old
In this study, researchers will learn more about BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at…
- Trial name
- BOLD (NCT06054893)
- Testing
- Omaveloxolone
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Biogen
MItochondrial Myopathies
RTA 408 Capsules in Patients With Mitochondrial Myopathy - MOTOR
Mitochondrial myopathies are a multisystemic group of disorders that are characterized by a wide range of biochemical and genetic mitochondrial defects and variable modes of inheritance.
- Trial name
- NCT02255422
- Testing
- Omaveloxolone capsules, 2.5 mg, omaveloxolone capsules, 5 mg, omaveloxolone capsules, 10 mg
- Where
- 9 sites in United States, Denmark
- Volunteers
- 53 people
- Sponsor
- Biogen
Distal Renal Tubular Acidosis
Study Evaluating Subjects With Distal Renal Tubular Acidosis
This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis in pediatric and…
- Trial name
- NCT03644706
- Testing
- ADV7103
- Where
- 8 sites in United States, Canada
- Volunteers
- 3 people
- Sponsor
- Advicenne Pharma