NCT03373786

Brief Summary

This is a Phase 1, open-label, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

December 22, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

October 22, 2017

Last Update Submit

April 21, 2022

Conditions

Alport Syndrome

Keywords

Kidney diseaseNephritisHereditary kidney diseaseHereditary nephritis

Outcome Measures

Primary Outcomes (2)

  • Safety - Adverse Events

    Incidence and severity of adverse events

    8 weeks

  • Effect of RG-012 on renal microRNA-21 (miR-21)

    Change in miR-21 expression in renal tissue

    8 weeks

Secondary Outcomes (3)

  • Pharmacokinetic (PK) parameter - Cmax

    8 weeks

  • Pharmacokinetic (PK) parameter - Tmax

    8 weeks

  • Pharmacokinetic (PK) parameter - AUC

    8 weeks

Study Arms (2)

RG-012 Single Dose

EXPERIMENTAL

1.5 mg/kg RG012 subcutaneous injection

Drug: RG012

RG012 Every Other Week

EXPERIMENTAL

1.5 mg/kg RG012 subcutaneous injections every other week

Drug: RG012

Interventions

RG012DRUG

RG012 in 0.3% sodium chloride

RG-012 Single DoseRG012 Every Other Week

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, ages 18 to 65 years
  • Confirmed diagnosis of Alport syndrome
  • eGFR between 40 and 90 mL/min/1.73m2
  • Proteinuria of at least 300 mg protein/g creatinine
  • For subjects taking an ACE inhibitor or an ARB, the dosing regimen should be stable for at least 30 days prior to screening
  • Willing to comply with contraception requirements

You may not qualify if:

  • Causes of chronic kidney disease aside from Alport syndrome (such as diabetic nephropathy, hypertensive nephropathy, lupus nephritis, or IgA nephropathy)
  • End stage renal disease (ESRD) as evidenced by ongoing dialysis therapy or history of renal transportation
  • Any other condition that may pose a risk to the subject's safety and well-being
  • Female subjects who are pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

eStudySite

La Mesa, California, 91942, United States

Location

Academic Medical Research Institute

Los Angeles, California, 90022, United States

Location

Apex Research of Riverside

Riverside, California, 92505, United States

Location

Eminence Medical & Clinical Research

Tampa, Florida, 33604, United States

Location

Houston Nephrology Research

Cypress, Texas, 77429, United States

Location

Utah Kidney Research Institute

Salt Lake City, Utah, 84107, United States

Location

Allegiance Research Specialists, LLC

Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Nephritis, HereditaryKidney DiseasesNephritis

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrologic DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Clinical Sciences & Operations, M.D.

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2017

First Posted

December 14, 2017

Study Start

December 22, 2017

Primary Completion

May 20, 2019

Study Completion

May 20, 2019

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Locations

US(7)