Non-contrast Enhanced MRI in Patients With C3 Glomerulopathy (C3G) or Immune-complex Membranoproliferative Glomerulonephritis (IC-MPGN) Enrolled in the ACH471-205 Study
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|ClinicalTrials.gov Identifier: NCT03723512|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2018
Last Update Posted : July 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|C3 Glomerulonephritis C3 Glomerulopathy Immune Complex Membranoproliferative Glomerulonephritis IC-MPGN Dense Deposit Disease||Device: Non contrast-enhanced magnetic resonance imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sub-project of the Clinical Protocol ACH471-205 "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"|
|Actual Study Start Date :||December 6, 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723512
|Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò|
|Ranica, BG, Italy, 24020|