Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

PHRR220906-004965

Unspecified

2022-CT0689

A Phase 2/3, Multicenter, Open-Label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy

Multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.

Start Date Duration in Months Target Completion Date Actual Completion Date
2022-08-20 79 2029-03-20 2029-03-30

Ongoing

Institution Classification Region LTO #
Otsuka Pharmaceutical Development and Commercialization, Inc. Private Business NCR
Institution Region
Otsuka Pharmaceutical Development and Commercialization, Inc. NCR
Name E-Mail Institution and Institution Address
Madonna U. Lozano mlozano@georgeclinical.com George Clinical Asia Pacific Ltd, Acceler8 Legazpi, UB, 111 Paseo De Roxas, Legazpi Village, Makati City, 1229, Philippines
Name E-Mail Institution and Institution Address
Madonna U. Lozano mlozano@georgeclinical.com George Clinical Asia Pacific Ltd, Acceler8 Legazpi, UB, 111 Paseo De Roxas, Legazpi Village, Makati City, 1229, Philippines
Name Expertise Affiliation
Anthony Russell T. Villanueva, M.D. Nephrology National Kidney and Transplant Institute
Arlene C. Crisostomo, MD Nephrology St. Luke's Medical Center - Quezon City
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
National Kidney and Transplant Institute * National Kidney and Transplant Institute Ethics Review Committee Anthony Russell T. Villanueva, M.D. Nephrology
St. Luke's Medical Center - Quezon City * St. Luke's Medical Center Institutional Ethics Review Board Arlene C. Crisostomo, MD Nephrology
Project Location Institutional Ethics Review Board
National Kidney and Transplant Institute National Kidney and Transplant Institute Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

Clinical Trial

Unspecified

Immunoglobulin A Nephropathy

Safety and Tolerability

Unspecified

Pending

Unspecified

Unspecified

2022-07-25

0000-00-00

No result found.

3

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0000-00-00

Subjects who completed Trial 417-201-00007 or VIS649-201 who could potentially benefit from treatment with sibeprenlimab for IgAN will be eligible. At screening, subjects must have estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m2.

Subjects who, in the previous trial, repeatedly failed to follow trial procedures or experienced treatment-limiting adverse events (AEs) considered related to IMP per investigator judgement that would preclude rollover into this trial will be excluded. At screening, subjects with nephrotic syndrome with concurrent hypoalbuminemia, hyperlipidemia, and edema will be excluded, but subjects with isolated nephrotic range proteinuria (> 3.5 g/day) will be eligible.

Interventional

Sibeprenlimab

Unspecified

None

Method of Allocation

Non-Randomized

Masking or Blinding

Open Label

Masking Details

Unspecified

Control

Unspecified

Assignment

Single

Phase

Phase II/III

Purpose of the Study

To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN.

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

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URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

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Participant Flow

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Adverse Events

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Outcome Measures

Unspecified

Brief Summary

Unspecified

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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