NCT03723512

Non-contrast Enhanced MRI in Patients With C3 Glomerulopathy (C3G) or Immune-complex Membranoproliferative Glomerulonephritis (IC-MPGN) Enrolled in the ACH471-205 Study

Completed NA Last updated 26 November 2021

What this trial tests

NA trial testing Non contrast-enhanced magnetic resonance imaging in C3 Glomerulonephritis in 7 participants. Completed in 17 February 2021.

Timeline

6 December 2018

Primary endpoint
17 February 2021

17 February 2021

Quick facts

Lead sponsor	Mario Negri Institute for Pharmacological Research
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	7
Start date	6 December 2018
Primary completion	17 February 2021
Estimated completion	17 February 2021
Sites	1 location across Italy

Drugs / interventions tested

• Non contrast-enhanced magnetic resonance imaging

Conditions studied

• C3 Glomerulonephritis — all drugs for C3 Glomerulonephritis →
• C3 Glomerulopathy — all drugs for C3 Glomerulopathy →
• Immune Complex Membranoproliferative Glomerulonephritis — all drugs for Immune Complex Membranoproliferative Glomerulonephritis →
• IC-MPGN — all drugs for IC-MPGN →

Sponsor

Mario Negri Institute for Pharmacological Research

Who can join

Adults 17 to 65, any sex, with C3 Glomerulonephritis or C3 Glomerulopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Functional and quantitative renal magnetic resonance imaging (MRI) has seen a number of recent advances, and techniques are now available that can generate quantitative imaging biomarkers with the potential to improve the management of kidney disease.

However, there are knowledge gaps that must be addressed before renal MRI methods could be more widely adopted in clinical research and ultimately be transferred to clinical practice, including the biological basis of different MRI biomarkers, and how the application of these biomarkers will improve patient care.

Among renal MRI techniques, renal diffusion weighted MRI (DWI) has been increasingly used in the last decade, showing high potential as a surrogate and monitoring biomarker for interstitial fibrosis in chronic kidney disease (CKD), as well as a surrogate biomarker for the inflammation in acute kidney diseases that may impact patient selection for renal biopsy in acute graft rejection.

Within the ready-to-start ACH471-205 clinical trial, an Open-Label Phase 2 Proof-of-Concept Study in Patients with C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) treated with ACH-0144471, aimed at evaluating the efficacy of 12 months of oral ACH-0144471 in patients with C3G or IC-MPGN, patients will undergo baseline and 12-month follow-up renal biopsies, and renal function will be assessed over time by estimated or measured (when available) glomerular filtration rate (GFR). Adding multi-parametric NCE-MRI to the examinations under the ACH471-205 study protocol will give the opportunity to elucidate, in a well-defined cohort of patients, the potential of NCE-MRI as biomarker of renal microstructure and functional change.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Complement Activation in Nephrotic Glomerular Diseases.
   Nell D, Wolf R, Podgorny PM, Kuschnereit T, et al · · 2024 · cited 3× · PMID 38398059 · DOI 10.3390/biomedicines12020455
2. Functional Magnetic Resonance Imaging to Monitor Disease Progression: A Prospective Study in Patients with Primary Membranoproliferative Glomerulonephritis.
   Villa G, Daina E, Brambilla P, Gamba S, et al · · 2024 · cited 1× · PMID 37926085 · DOI 10.1159/000534893