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A PILOT PROOF-OF–CONCEPT STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 6 MONTHS RAVULIZUMAB TREATMENT IN PATIENTS WITH FLARES OF CORTICOSTEROID-RESISTANT IDIOPATHIC IgA NEPHROPATHY

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512154-24-00
Acronym
RAV-IgA
Enrollment
15
Registered
2024-06-28
Start date
2023-05-26
Completion date
Unknown
Last updated
2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA nephropathy

Brief summary

Quantitative reduction of proteinuria and haematuria (based on 24-hr urine collection(s)) from baseline to Week 26 (6 months after starting treatment with ravulizumab)

Detailed description

Percentage of participants achieving complete remission 26 weeks after treatment with ravulizumab, Evolution of proteinuria and haematuria (based on 24- hr urine collection(s)) after treatment withdrawal (from Week 26 to Week 46), To measure the evolution of serum creatinine levels (quantitative) from baseline to Week 46, To measure the evolution of urine C5b-9 levels (quantitative) from baseline to Week 46, To measure the slope of eGFR computed from baseline to Week 46, Proportion of patients discontinuing treatment with ravulizumab due to adverse effects associated with the drug

Interventions

Sponsors

Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre, Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Quantitative reduction of proteinuria and haematuria (based on 24-hr urine collection(s)) from baseline to Week 26 (6 months after starting treatment with ravulizumab)

Secondary

MeasureTime frame
Percentage of participants achieving complete remission 26 weeks after treatment with ravulizumab, Evolution of proteinuria and haematuria (based on 24- hr urine collection(s)) after treatment withdrawal (from Week 26 to Week 46), To measure the evolution of serum creatinine levels (quantitative) from baseline to Week 46, To measure the evolution of urine C5b-9 levels (quantitative) from baseline to Week 46, To measure the slope of eGFR computed from baseline to Week 46, Proportion of patients discontinuing treatment with ravulizumab due to adverse effects associated with the drug

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026