Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT06797609
Active, not recruiting Observational

Comparing the Performance of Serum Creatinine and Cystatin C-based GFR Estimations in Predicting Directly Measured GFR in Patients With or Without Nephrotic Syndrome

NCT06797609 · tracked via the Priya Life Science Italy tracker
Sponsor
Mario Negri Institute for Pharmacological Research
Phase
Observational
Started
2025-04-01
Last updated
2025-09-04

Condition(s) studied

Nephrotic Syndrome

Investigational drug(s) / intervention(s)

Sample analyses

Sample analyses: Immunoturbidimetric assay for determination of serum Cys-C levels and the Chronic Kidney Disease Epidemiology (CKD-EPI) equation for GFR estimation

Study summary

This observational study relates to subjects with primary membranous nephropathy enrolled in the ongoing PEPTIDE, MONET, and ORION clinical trials performed and coordinated by IRFMN (NCT04095156, NCT04893096, and NCT05050214 respectively) to assess the efficacy of anti-CD20 or anti-CD38 monoclonal antibodies (rituximab and obinutuzumab) or anti-CD38 monoclonal antibody (felzartamab) therapy in inducing remission of NS during 1-year follow-up.

Serum samples for measurement of Cystatin C (Cys-C), a low-molecular-weight protein, will be identified among those of the patients with NS who provided consent to store their samples at the Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò", Ranica (BG) in the certified biobank UNI EN ISO 9001:2015; certification n° 6121 - Centro di Risorse Biologiche Mario Negri - Biobanca Malattie Rare e Malattie Renali (CRB).

Measured GFR by plasma clearance of iohexol, as well as serum Cr or CKD EPI values in addition to the hematochemical and urinary parameters, are already available because measured during the studies in which the subjects were enrolled.

Serum samples will be tested by Laboratorio Analisi Chimico-Cliniche Area Specialistica del Settore Autoimmunità ASST Papa Giovanni XXIII, Bergamo.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subjects enrolled in the PEPTIDE, MONET, and ORION clinical trials (NCT04095156, NCT04893096, and NCT05050214 respectively). * Provision of written informed consent consent to store samples at the Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò", Ranica (BG) in the certified biobank UNI EN ISO 9001:2015; certification n° 6121 - Centro di Risorse Biologiche Mario Negri - Biobanca Malattie Rare e Malattie Renali (CRB). Exclusion Criteria: * Subjects not enrolled in the above mentioned trials.

Primary outcome measure(s)

  • Accuracy of eGRF equation — Measurements at baseline and at 1 year after treatment.
    To assess the accuracy of the eGFR equation using serum creatinine and cystatin C to estimate mGFR, evaluated using the Concordance Correlation Coefficient (CCC) as the primary indicator.

Trial sites (2)

FacilityCityRegionStatus
ASST Papa Giovanni XXIII Bergamo BG
Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò Ranica BG

More Mario Negri Institute for Pharmacological Research trials in Italy

Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (ASST Papa Giovanni XXIII) Active, not recruiting
Simulated and Synthetic Health Data: Improving Clinical Research on Rare Diseases. A Real-World Data Simulation of Autosomal Dominant Polycystic Kidney Disease (ADPKD) Trials. A Retrospective, Observational Study Active, not recruiting
Developing a Pipeline to Employ RNA-Seq as a Complementary Diagnostic Tool in Rare Diseases Recruiting
Severe Acquired Brain Injuries: Prognostic Factors and Quality of Care Recruiting
Health-care Quality in Semi-intensive Care Units Recruiting

Other trials for the same condition

Multitarget Strategy for Primary Podocytopathies Recruiting
Autoantibodies Against-nephrin in Idiopathic Nephrotic Syndrome Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06797609 on ClinicalTrials.gov ↗ ← All trials in Italy