An observational study in Kidney Diseases, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to participants aged 0 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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.
3,838 studies on the registry are indexed under Kidney Diseases; 498 are open to participants now.
This study's planned enrollment of 100 is below the median of 192 across 1,032 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Diagnosis of primary C3G confirmed by the results of morphological and clinical studies.
Other: No intervention
Diagnosis of primary IC-MPGN confirmed by the results of morphological and clinical studies.
Other: No intervention
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
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).
Time frame: 12 months
Number and proportion of patients with complete remission
Complete remission was defined as proteinuria \<0.5 g/24 h with a stable eGFR (less than 20% decline in eGFR from baseline without the needs for renal replacement therapy).
Time frame: 6 months; 12 months
Number and proportion of patients with partial remission
Partial remission was defined as a reduction in proteinuria at stable eGFR (no decrease of \>20% of baseline): \>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)
Time frame: 6 months; 12 months
Number and proportion of patients with relapse
Clinical relapse was defined as a proteinuria \>3.5 g/24h after achieving complete remission or, in those with partial remission, as an increase of proteinuria \>50% compared with the lowest value during remission with recurrence of NS
Time frame: 6 months; 12 months
Number and proportion of patients with progression
Composite progression defined as 40% eGFR decline from the baseline and/or eGFR \<15 mL/min per 1.73 m2 and/or renal replacement therapy
Time frame: 6 months; 12 months
Number and proportion of patients with progression to end-stage kidney disease
Number and proportion of patients with progression to end-stage kidney disease from index-date up to 12 months
Time frame: 6 months; 12 months
Number and proportion of died patients
Number and proportion of patients who died from index date up to 12 months
Time frame: 6 months; 12 months
Time to start of maintenance dialysis
Time in months from index date to start of maintenance dialysis
Time frame: 6 months; 12 months
Time from the diagnosis date to the start date of dialysis
Time in months from the diagnosis date to the start date of dialysis
Time frame: 6 months; 12 months
Time from the start date of treatment to the start date of dialysis
Time in months from first treatment date to the start date of dialysis
Time frame: 6 months; 12 months
Time from the diagnosis date to transplantation
Time in months from the diagnosis date to transplantation
Time frame: 6 months; 12 months
Time from the diagnosis date to the date of complete remission
Time in months from the diagnosis date to the date of complete remission
Time frame: 6 months; 12 months
Time from the diagnosis date to the date of partial remission
Time in months from the diagnosis date to the date of partial remission
Time frame: 6 months; 12 months
Time from the diagnosis date to the date of overall remission (complete and partial remission)
Time in months from the diagnosis date to the date of overall remission (complete and partial remission)
Time frame: 6 months; 12 months
Time to progression
Time in months from the diagnosis date to progression
Time frame: 6 months; 12 months
Number and proportion of patients with a) an increase in eGFR by ≥15% from the baseline; b) decrease in eGFR by ≥15% from the baseline; c) stable eGFR (change up to 15%)
Number and proportion of patients with a) an increase in eGFR by ≥15% from the baseline; b) decrease in eGFR by ≥15% from the baseline; c) stable eGFR (change up to 15%) from index date up to 12 months
Time frame: 6 months; 12 months
Time to 30%, 40% and 50% decline in eGFR
Time in months from index date to 30%, 40% and 50% decline in eGFR
Time frame: 6 months; 12 months
Number and proportion of patients with proteinuria >1 g/24 h and eGFR ≥30 mL/min per 1.73 m2
Number and proportion of patients with proteinuria \>1 g/24 h and eGFR ≥30 mL/min per 1.73 m2 from index date up to 12 months
Time frame: 6 months; 12 months
Number and proportion of patients with nephrotic syndrome
Number and proportion of patients with nephrotic syndrome from index date up to 12 months
Time frame: 6 months; 12 months
Demographic and clinical characteristics of patients with primary C3G (cohort 1), IC-MPGN (cohort 2), and overall
Number and proportion of patients by age, gender, BMI, BSA, family history of kidney disease, transplant status, blood pressure, laboratory markers: serum creatinine level (µmol/L), eGFR, urinary blood cell (RBCs/hpf), proteinuria (g/24h), serum albumin (g/L); eGFR rate of change; chronic kidney disease (CKD) stage; proteinuria ≥1 g/24 h AND eGFR ≥30 mL/min per 1.73 m2
Time frame: Baseline
Number of patients by morphologically verified disease form in patients with primary C3G (cohort 1), IC-MPGN (cohort 2), and overall
Morphologically verified disease form: DDD (subject to electron microscopy), C3GN (subject to electron microscopy), C3G (in the absence of informative electron microscopy data), IC-MPGN.
Time frame: Baseline
Number of patients with presence of serum complement markers, serum factor H, rare genetic variants
Number of patients with presence of serum complement markers (C3, C4, CH50, C5a), serum factor H, rare genetic variants at baseline
Time frame: Baseline
Number and proportion of patients stratified by treatment sequence and specific regimen of treatment
Number and proportion of patients stratified by treatment sequence and specific regimen of treatment
Time frame: Baseline; 6 months; 12 months
Number and proportion of patients that discontinued a specific regimen of treatment at each line of therapy at any time during follow-up and reason for discontinuation for each cohort
Number and proportion of patients that discontinued a specific regimen of treatment at each line of therapy at any time during follow-up and reason for discontinuation for each cohort
Time frame: Baseline; 6 months; 12 months
Number of exposed doses for non-continuous treatments (e.g., pulse therapy, rituximab infusion) in each cohort
Number of exposed doses for non-continuous treatments (e.g., pulse therapy, rituximab infusion) in each cohort
Time frame: Baseline; 6 months; 12 months
Number of patients by qualitative, semi-quantitative and quantitative scores of active and chronic lesions
1. mesangial proliferation (% of glomeruli), 2. endocapillary hypercellularity (% of glomeruli), 3. membranoproliferative morphology (thickening and/or double contouring of the capillary basement membranes), 4. leukocyte infiltration, 5. proportion of completely intact glomeruli (%) 6. proportion of cellular (%), fibrous (%), fibrocellular (%) crescents, 7. fibrinoid necrosis, 8. interstitial infiltration, 9. interstitial fibrosis (%), 10. tubular atrophy (%), 11. global and segmental glomerulosclerosis (quantitatively, % of all glomeruli) 12. arteriosclerosis and arteriolosclerosis
Time frame: Baseline
Number of patients with signs of thrombotic microangiopathy in the biopsy specimen
Number of patients with signs of thrombotic microangiopathy in the biopsy specimen at baseline
Time frame: Baseline
Number of patients with acute tubular necrosis
Number of patients with acute tubular necrosis at baseline
Time frame: Baseline
Number of patients with presence of C1q, IgA, IgM, IgG, C3, kappa chain, lambda chain deposits
Number of patients with presence of C1q, IgA, IgM, IgG, C3, kappa chain, lambda chain deposits at baseline
Time frame: Baseline
Patient-reported outcomes for C3G (cohort 1), IC-MPGN (cohort 2), and overall
1. Descriptive adherence data based on question score 2. Patient-reported outcomes, SF-36 (RAND)
Time frame: 12 months
Number of patients (%) with adverse events/serious adverse events by treatment option
Number of patients (%) with adverse events/serious adverse events by treatment option from index date up to 12 months
Time frame: 12 months
Change from baseline of systolic and diastolic blood pressure (BP) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline of systolic and diastolic blood pressure (BP) (with percentiles for children) at 6 and 12 month
Time frame: 6 months; 12 months
Change from baseline serum creatinine level (µmol/L) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline serum creatinine level (µmol/L) at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline estimated glomerular filtration rate (eGFR) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline estimated glomerular filtration rate (eGFR) at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline eGFR rate of change over time (eGFR slope) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline eGFR rate of change over time (eGFR slope) at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline chronic kidney disease (CKD) stage (number of patients, %) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline chronic kidney disease (CKD) stage (number of patients, %) at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline red blood cell count in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline red blood cell (RBC) count at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline RBC casts in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline RBC casts at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline daily proteinuria (proteinuria in g/24 hours) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline daily proteinuria (proteinuria in g/24 hours) at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline proteinuria >1 g/24 h in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline proteinuria \>1 g/24 h at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline eGFR ≥30 mL/min per 1.73 m2 in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline eGFR ≥30 mL/min per 1.73 m2 at 6 and 12 months
Time frame: 6 months; 12 months
Change from baseline number of patients with nephrotic syndrome (%) in patients with C3G (cohort 1), IC-MPGN (cohort 2), and overall
Change from baseline number of patients with nephrotic syndrome (%) at 6 and 12 months
Time frame: 6 months; 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.