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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 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-09-04

No results posted yet for this 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.

Conditions

  • Nephrotic Syndrome

Interventions

OTHER

Sample analyses

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

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Giuseppe Remuzzi, MD · Istituto Di Ricerche Farmacologiche Mario Negri

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797609 on ClinicalTrials.gov