Clinical Outcomes of C3 Glomerulopathy and IC-MPGN in Russia: Hybrid Retrospective - Prospective Study

NCT06851845 | Not Yet Recruiting

• 1 other identifier: CLNP023B1RU01
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is planned to study specificity of the clinical course and treatment outcomes of C3 glomerulopathy (C3G) and Immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged under 18 years and 18 years and older in the Russian population in 2025-2028. The primary objective of the study is to estimate the frequency of complete or partial remission 12 months after morphological verification of the diagnosis. Assessment of demographic, clinical and laboratory, morphological characteristics at diagnosis and their relationship with the disease outcomes, primarily the disease progression and development of chronic renal failure, will allow assessing the efficacy of treatment used in real clinical practice, disease prognosis and factors associated with unfavourable outcomes.

Conditions

Kidney Diseases

Keywords

glomerulopathy

Outcome Measures

Primary Outcomes (1)

• Number and proportion of patients with overall (complete + partial) remission following the standard therapy in Russia

  Complete response is defined as proteinuria \<0.5 g/24 h with stable eGFR (less than 20% decline in eGFR from baseline without the need for renal replacement therapy). Partial response is defined as reduction of proteinuria at stable eGFR (no decrease of \>20% of baseline value): \>50% (from baseline) (in those with proteinuria \<3.5 g/day or \>3.5 g/day but without nephrotic syndrome (NS)) OR in ≥50% from baseline accompanied by a regression of NS (NS \<3.5 g/day and blood albumin ≥30 g/L).

  12 months

Secondary Outcomes (41)

• Number and proportion of patients with complete remission

  6 months; 12 months

• Number and proportion of patients with partial remission

  6 months; 12 months

• Number and proportion of patients with relapse

  6 months; 12 months

• Number and proportion of patients with progression

  6 months; 12 months

• Number and proportion of patients with progression to end-stage kidney disease

  6 months; 12 months

Study Arms (2)

C3 glomerulopathy

Diagnosis of primary C3G confirmed by the results of morphological and clinical studies.

Other: No intervention

Immune-complex membranoproliferative glomerulonephritis

Diagnosis of primary IC-MPGN confirmed by the results of morphological and clinical studies.

Other: No intervention

Interventions

No intervention OTHER

Patients will receive medical care in accordance with the routine practice of disease treatment

Also known as: Treatment includes the following options:, ACEi/ARB alone, ACEi/ARB + corticosteroids, ACEi/ARB + MMF, ACEi/ARB + SGLT2i, ACEi/ARB + MMF + corticosteroids, ACEi/ARB + cyclophosphamide, Corticosteroids alone, MMF alone, Cyclophosphamide alone, Corticosteroids + MMF, Rituximab, Anticomplement therapy, Other immunosuppressants

C3 glomerulopathy; Immune-complex membranoproliferative glomerulonephritis

Eligibility Criteria

• Age: 0 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will recruit adults (aged 18 years and older) and pediatric patients (legally acceptable representatives) with biopsy-confirmed diagnosis of primary C3G or idiopathic IC-MPGN in the period from March 2024 to February 2027, who will meet the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• Willing to sign informed consent form. If the patient is under 18 years of age, the parent or legally acceptable representative of the child/adolescent who can participate in this study also signs the consent form.
• Diagnosis of primary C3G or IC-MPGN confirmed by the results of morphological and clinical studies.
• The results of serum creatinine level, proteinuria determination obtained not earlier than 4 weeks before the kidney biopsy
• Index date (kidney biopsy) not earlier than March 2024 and not later than 11 months before signing the ICF
• The estimated baseline GFR (using the CKD-EPI formula for persons aged over 18 years and the modified Schwarz formula for children) or the measured GFR is ≥30 mL/min per 1.73 m2.

You may not qualify if:

• Patients participating in a clinical trial with the investigational product.
• Patients with monoclonal gammopathies (myeloma, B-cell lymphoma/lymphocytic leukemia, lymphoplasmacytoma)
• Patients with systemic autoimmune diseases and vasculitis (systemic lupus erythematosus, systemic sclerosis, dermatomyositis, mixed connective tissue disease, Sjogren syndrome, Henoch-Schönlein purpura, ANCA vasculitis, cryoglobulinemia)
• Patients with current or recent infections (viral hepatitis B, viral hepatitis C, infective endocarditis or sepsis, infected ventriculoatrial shunts, abscesses, meningococcal and other bacterial infections, protozoan infections)
• Patients with any clinically significant acute disease within 30 days prior to kidney biopsy
• Clinically significant concomitant kidney disease
• Treatment with pegcetacoplan

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Kidney Diseases

Interventions

Adrenal Cortex Hormones; Cyclophosphamide; Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 28, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share