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

C3 Glomerulopathy Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723512
• Other study ID #: Subproject MRI ACH471-205
• Status: Completed
• Phase: N/A
• Start date: December 6, 2018
• Est. completion date: February 17, 2021

Study information

• Verified date: November 2021
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of C3G or IC-MPGN;

• Patients enrolled in the ACH471-205 study at the Bergamo center;

• No contraindications to perform MRI.

Exclusion Criteria:

• Ferro-magnetic prosthesis, aneurysm clips, severe claustrophobia or other contraindications or exclusions interfering with the MRI assessment.

Related Conditions & MeSH terms

• C3 Glomerulonephritis
• C3 Glomerulopathy
• Dense Deposit Disease
• Glomerulonephritis
• Glomerulonephritis, Membranoproliferative
• IC-MPGN
• Immune Complex Membranoproliferative Glomerulonephritis

Intervention

Device:
• Non contrast-enhanced magnetic resonance imaging
Non contrast-enhanced magnetic resonance imaging

Locations

Country	Name	City	State
Italy	Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò	Ranica	BG

Sponsors (2)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	Alexion Pharmaceuticals

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Caroli A, Schneider M, Friedli I, Ljimani A, De Seigneux S, Boor P, Gullapudi L, Kazmi I, Mendichovszky IA, Notohamiprodjo M, Selby NM, Thoeny HC, Grenier N, Vallée JP. Diffusion-weighted magnetic resonance imaging to assess diffuse renal pathology: a systematic review and statement paper. Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii29-ii40. doi: 10.1093/ndt/gfy163. — View Citation

Selby NM, Blankestijn PJ, Boor P, Combe C, Eckardt KU, Eikefjord E, Garcia-Fernandez N, Golay X, Gordon I, Grenier N, Hockings PD, Jensen JD, Joles JA, Kalra PA, Krämer BK, Mark PB, Mendichovszky IA, Nikolic O, Odudu A, Ong ACM, Ortiz A, Pruijm M, Remuzzi G, Rørvik J, de Seigneux S, Simms RJ, Slatinska J, Summers P, Taal MW, Thoeny HC, Vallée JP, Wolf M, Caroli A, Sourbron S. Magnetic resonance imaging biomarkers for chronic kidney disease: a position paper from the European Cooperation in Science and Technology Action PARENCHIMA. Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii4-ii14. doi: 10.1093/ndt/gfy152. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median diffusivity (D) in the kidney, renal cortex and medulla.		At baseline (prior to baseline biopsy).
Primary	Median diffusivity (D) in the kidney, renal cortex and medulla.		At 12 months (prior to follow-up biopsy).
Secondary	Renal artery blood flow and renal plasma flow.		At baseline (prior to baseline biopsy).
Secondary	Renal artery blood flow and renal plasma flow.		At 12 months (prior to follow-up biopsy).
Secondary	Change in median diffusivity in the kidney, renal cortex and medulla after 12-month treatment with ACH-0144471.		At 12 months follow-up.
Secondary	Change in renal artery blood flow and renal plasma flow after 12-month treatment with ACH-0144471.		At 12 months follow-up.