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 | Active Not Recruiting

• 1 other identifier: Cy-STEM
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

nephrotic syndrome; GFR; GFR estimation; tubular handling; cystatin C; creatinine

Outcome Measures

Primary Outcomes (1)

• Accuracy of eGRF equation

  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.

  Measurements at baseline and at 1 year after treatment.

Study Arms (1)

Patients

Subjects with primary membranous nephropathy enrolled in the PEPTIDE, MONET, and ORION clinical trials performed and coordinated by IRFMN (NCT04095156, NCT04893096, and NCT05050214 respectively) 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).

Other: Sample analyses

Interventions

Sample analyses OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary membranous nephropathy.

You may qualify if:

• 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).

You may not qualify if:

• Subjects not enrolled in the above mentioned trials.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (2)

ASST Papa Giovanni XXIII

Bergamo, BG, 24027, Italy

Location

Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò

Ranica, BG, 24020, Italy

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Giuseppe Remuzzi, MD

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)