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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
Sponsor:
Collaborator:
Achillion Pharmaceuticals
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
Experimental: Whole group
Whole group
Device: Non contrast-enhanced magnetic resonance imaging
Non contrast-enhanced magnetic resonance imaging




Primary Outcome Measures :
  1. Median diffusivity (D) in the kidney, renal cortex and medulla. [ Time Frame: At baseline (prior to baseline biopsy). ]
  2. Median diffusivity (D) in the kidney, renal cortex and medulla. [ Time Frame: At 12 months (prior to follow-up biopsy). ]

Secondary Outcome Measures :
  1. Renal artery blood flow and renal plasma flow. [ Time Frame: At baseline (prior to baseline biopsy). ]
  2. Renal artery blood flow and renal plasma flow. [ Time Frame: At 12 months (prior to follow-up biopsy). ]
  3. 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. ]
  4. Change in renal artery blood flow and renal plasma flow after 12-month treatment with ACH-0144471. [ Time Frame: At 12 months follow-up. ]


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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Locations
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Italy
Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò
Ranica, BG, Italy, 24020
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Achillion Pharmaceuticals

Publications:
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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03723512     History of Changes
Other Study ID Numbers: Subproject MRI ACH471-205
First Posted: October 29, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario Negri Institute for Pharmacological Research:
Non-contrast enhanced MRI
Diffusivity
Renal microstructure
Renal function
C3G
IC-MPGN
Additional relevant MeSH terms:
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Glomerulonephritis
Glomerulonephritis, Membranoproliferative
Nephritis
Kidney Diseases
Urologic Diseases
Immune System Diseases
Antigen-Antibody Complex
Immunologic Factors
Physiological Effects of Drugs