Clinical trials: Alport Syndrome
Alport Syndrome
A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome
Alport syndrome (AS) is a rare genetic condition that causes kidney disease, hearing loss, and eye abnormalities that occur due to changes in specific genes (COL4A3, COL4A4, and COL4A5).
- Trial name
- ASSESS (NCT07211685)
- Testing
- BAY 3401016
- Where
- 58 sites in United States, Argentina and 13 more
- Volunteers
- 60 people
- Sponsor
- Bayer
Alport Syndrome
A Study of ELX-02 in Patients With Alport Syndrome
This is a Phase 2 open label pilot study to evaluate the safety and efficacy of subcutaneously administered ELX-02 in patients with X-linked or autosomal recessive Alport Syndrome with Col4A5 and Col4A3/4 nonsense mutation.
- Trial name
- NCT05448755
- Testing
- ELX-02
- Where
- 4 sites in Australia, United Kingdom
- Volunteers
- 3 people
- Sponsor
- Eloxx Pharmaceuticals, Inc.
Alport Syndrome, Focal Segmental Glomerulosclerosis
Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental Glomerulosclerosis
This is a Phase 2, Multi-center, Open-Label Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of R3R01 in Alport Syndrome Patients with Uncontrolled Proteinuria on ACE/ARB Inhibition and in Patients with Primary…
- Trial name
- NCT05267262
- Testing
- R3R01
- Where
- 22 sites in United States, Belgium and 4 more
- Volunteers
- 43 people
- Sponsor
- River 3 Renal Corp.
Alport Syndrome
Study of Lademirsen (SAR339375) in Patients With Alport Syndrome
Primary Objectives: To assess the efficacy of lademirsen (SAR339375) in reducing the decline in renal function. To assess the safety and tolerability of lademirsen (SAR339375) in participants with Alport syndrome.
- Trial name
- HERA (NCT02855268)
- Testing
- lademirsen (SAR339375)
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 43 people
- Sponsor
- Genzyme, a Sanofi Company
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
The primary objective of this multicenter observational registry is to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry, including…
- Conditions
- Antiphospholipid (aPL)-Positive, Rheumatic Arthritis, Celiac Disease, Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- MERIT (NCT07892651)
- Where
- Jordan
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Axiom Bioregistry
Alport Syndrome
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL
This international, multi-center, Phase 2/3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with Alport syndrome.
- Trial name
- CARDINAL (NCT03019185)
- Testing
- Bardoxolone Methyl
- Where
- 63 sites in United States, Australia and 6 more
- Volunteers
- 187 people
- Sponsor
- Biogen
Alport Syndrome
Vonafexor ALPort Syndrome Efficacy & Safety TRIAl-1 (ALPESTRIA-1)
This study is a proof-of-concept trial of vonafexor safety, its effects on kidney function in subjects with at risk of progression Alport syndrome.
- Trial name
- ALPESTRIA-1 (NCT06425055)
- Testing
- Vonafexor
- Where
- 13 sites in United States, France and 1 more
- Volunteers
- 26 people
- Sponsor
- Enyo Pharma
Alport Nephropathy
Urine, DNA and Clinical Information Collection From Patients With Alport Nephropathy.
This biomarker study is a follow-up to CPLATFRM2201. The goal of CBASICHR0005 is to collect another urine sample, interval clinical information, and an optional DNA sample from as many of the original 80 patients as possible.
- Trial name
- NCT03074357
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Nephritis, Hereditary, Hematuria-Nephropathy-Deafness Syndrome
Biomarker for Alport Syndrome (BioAlport)
International, multicenter, observational, longitudinal monitoring study to identify biomarker/s for Alport syndrome and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s
- Trial name
- BioAlport (NCT02718027)
- Where
- 7 sites in Albania, Georgia and 5 more
- Volunteers
- 12 people
- Sponsor
- CENTOGENE GmbH Rostock
Alport Syndrome
A Study of RG-012 in Subjects With Alport Syndrome
This is a Phase 1, open-label, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome.
- Trial name
- NCT03373786
- Testing
- RG012
- Where
- 7 sites in United States
- Volunteers
- 4 people
- Sponsor
- Genzyme, a Sanofi Company
Alport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2
ATHENA: Natural History of Disease Study in Alport Syndrome Patients
There is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients.
- Trial name
- RG012-01 (NCT02136862)
- Where
- 15 sites in United States, Australia and 4 more
- Volunteers
- 165 people
- Sponsor
- Genzyme, a Sanofi Company
Focal Segmental Glomerulosclerosis, Minimal Change Disease
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
To evaluate the safety, efficacy and tolerability of sparsentan oral suspension and tablets, and assess changes in proteinuria after once-daily dosing over 108 weeks.
- Conditions
- Focal Segmental Glomerulosclerosis, Minimal Change Disease, Immunoglobulin A Nephropathy, IgA Vasculitis
- Trial name
- EPPIK (NCT05003986)
- Testing
- Sparsentan
- Where
- 47 sites in United States, Germany and 6 more
- Volunteers
- 67 people
- Sponsor
- Travere Therapeutics, Inc.
Chronic Kidney Diseases, Alport Syndrome
An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)
This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with…
- Conditions
- Chronic Kidney Diseases, Alport Syndrome, Autosomal Dominant Polycystic Kidney
- Trial name
- EAGLE (NCT03749447)
- Testing
- Bardoxolone methyl
- Where
- 87 sites in United States, Australia and 4 more
- Volunteers
- 270 people
- Sponsor
- Biogen
Alport Syndrome
Human Urine Sample Collection for Alport Nephropathy Biomarker Studies
This is a prospective cross-sectional, observational, single-center study of Alport patients, in which a single, first morning voided urine collection will be acquired and used to validate assays of urine biomarkers that reflect…
- Trial name
- NCT01602835
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Alport Syndrome
A Study to Evaluate Setanaxib in Patients With Alport Syndrome
The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment.
- Trial name
- NCT06274489
- Testing
- Setanaxib
- Where
- 17 sites in Austria, Czechia and 3 more
- Volunteers
- 20 people
- Sponsor
- Calliditas Therapeutics AB
Alport Syndrome, X-Linked, Alport Syndrome, Autosomal Recessive
EXACT Study: A Blinded Study in Patients With Alport Syndrome to Evaluate Exaluren Efficacy and Safety
This is a randomized, double-Blind, placebo-controlled study to evaluate the efficacy and safety of exaluren in Alport Syndrome patients with nonsense mutations in COL4A3/4/5 genes.
- Trial name
- NCT07523581
- Testing
- Exaluren
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 24 people
- Sponsor
- Eloxx Pharmaceuticals, Inc.
IgA Nephropathy, Focal Segmental Glomerulosclerosis
Atrasentan in Patients With Proteinuric Glomerular Diseases
The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.
- Conditions
- IgA Nephropathy, Focal Segmental Glomerulosclerosis, Alport Syndrome, Diabetic Kidney Disease
- Trial name
- AFFINITY (NCT04573920)
- Testing
- Atrasentan
- Where
- 33 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- Novartis Pharmaceuticals