Kidney Diseases Clinical Trial
Official title:
A Multi-centre, Open-label, Single-group Exploratory Trial of the Safety and Activity of Sparsentan for the Treatment of Incident Patients With Immunoglobulin A Nephropathy
To determine the nephroprotective potential of treatment with sparsentan in patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy.
A multi-centre, open-label, single-group trial is proposed to explore the safety of, and response to sparsentan treatment in incident, renin angiotensin system (RAS) blockade-naïve patients with biopsy-proven immunoglobulin A nephropathy (IgAN). The purpose is to explore sparsentan treatment as a potential first-line treatment in patients newly diagnosed with IgAN (ie, incident patients), who have thus not received prior treatment with ACEI or ARB therapy for IgAN. Response to treatment will be assessed as changes from baseline rather than comparison to another treatment, and will be based on established proteinuria endpoints (UPCR and protein excretion), and glomerular filtration rate (GFR); a number of exploratory measures will be assessed as well. The starting dose of sparsentan will be 200 mg/day, which will be titrated up to the target dose of 400 mg/day at Week 2. Patients who do not tolerate the target dose will have their dose reduced back to 200 or 100 mg/day; throughout the study, patients will be maintained on the maximum allowed dose of sparsentan they can tolerate. All patients will be treated with sparsentan for a total of 110 weeks, followed by an off-treatment follow-up period of 4 weeks. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03246984 -
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
|
N/A | |
| Completed |
NCT03545113 -
Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease
|
N/A | |
| Recruiting |
NCT05100017 -
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
|
N/A | |
| Recruiting |
NCT04559321 -
Holmium Vs Trilogy Kidney Stones GUY's 1-2
|
Phase 3 | |
| Recruiting |
NCT05036850 -
China Kidney Patient Trials Network
|
||
| Completed |
NCT04037436 -
Functional Exercise and Nutrition Education Program for Older Adults
|
N/A | |
| Active, not recruiting |
NCT01529658 -
Renal Hypothermia During Partial Nephrectomy
|
N/A | |
| Completed |
NCT01679587 -
Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)
|
Phase 1 | |
| Completed |
NCT01155141 -
Idiopathic Focal Segmental Glomerulosclerosis (FSGS) and Treatment With ACTH
|
Phase 4 | |
| Completed |
NCT00755690 -
Study of Dietary Phosphate and Mineral Homeostasis in Early Chronic Kidney Disease
|
N/A | |
| Recruiting |
NCT05759754 -
Effects of Traditional Chinese Medicine (GSJYF) in Children With Inherited Proteinuric Kidney Disease
|
N/A | |
| Completed |
NCT03213158 -
Ixazomib for Desensitization
|
Phase 2 | |
| Active, not recruiting |
NCT02237352 -
Mechanisms of Diabetic Nephropathy in Ecuador
|
||
| Recruiting |
NCT06067867 -
Kidney and Pregnancy Registry
|
||
| Recruiting |
NCT04110080 -
Enhanced Recovery After Surgery in Kidney Transplant Donors
|
N/A | |
| Active, not recruiting |
NCT04876963 -
HOLT-ED: Holter-monitoring in End-stage Renal Disease
|
||
| Enrolling by invitation |
NCT05324878 -
Honoring Individual Goals and Hopes: Implementing Advance Care Planning for Persons With Kidney Disease on Dialysis
|
||
| Not yet recruiting |
NCT03899298 -
Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions
|
Phase 1 | |
| Active, not recruiting |
NCT04631965 -
Healthcare Transition of Adolescents With Chronic Health Conditions
|
||
| Completed |
NCT03394859 -
Electronic Medical Records and Genomics (eMERGE) Phase III
|