An interventional study of Non contrast-enhanced magnetic resonance imaging in C3 Glomerulonephritis, C3 Glomerulopathy and Immune Complex Membranoproliferative Glomerulonephritis, sponsored by Mario Negri Institute for Pharmacological Research. Completed at 1 site in Italy. Open to participants aged 17 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-11-26.
Sponsored by Mario Negri Institute for Pharmacological Research · Not applicable, Interventional, and Diagnostic
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.
149 studies on the registry are indexed under Glomerulonephritis; 38 are open to participants now.
This study's enrollment of 7 is below the median of 40 across 112 interventional studies indexed under Glomerulonephritis.
Browse Glomerulonephritis studies →Mario Negri Institute for Pharmacological Research is the lead sponsor of 159 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Whole group
Device: Non contrast-enhanced magnetic resonance imaging
Non contrast-enhanced magnetic resonance imaging
Median diffusivity (D) in the kidney, renal cortex and medulla.
Time frame: At baseline (prior to baseline biopsy).
Median diffusivity (D) in the kidney, renal cortex and medulla.
Time frame: At 12 months (prior to follow-up biopsy).
Renal artery blood flow and renal plasma flow.
Time frame: At baseline (prior to baseline biopsy).
Renal artery blood flow and renal plasma flow.
Time frame: At 12 months (prior to follow-up biopsy).
Change in median diffusivity in the kidney, renal cortex and medulla after 12-month treatment with ACH-0144471.
Time frame: At 12 months follow-up.
Change in renal artery blood flow and renal plasma flow after 12-month treatment with ACH-0144471.
Time frame: At 12 months follow-up.
Plan to share: Undecided
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Mario Negri Institute for Pharmacological Research