Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New antibody drug shows promise for kidney disease

NCT ID NCT05065970

Disease control Sponsor: HI-Bio, A Biogen Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested a drug called felzartamab in 54 adults with IgA nephropathy, a kidney disease that can lead to kidney failure. The drug targets immune cells to reduce protein leakage in urine, a sign of kidney damage. The study compared felzartamab to a placebo to see if it safely lowers protein levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Felzartamab (a monoclonal antibody that targets CD38 on immune cells)
What this could lead to
If successful, this could point toward a new treatment to control IgA nephropathy and reduce kidney damage.
What could go wrong
This is an early Phase 2 trial with only 54 participants, so results may not hold up in larger studies. The drug may cause side effects or fail to improve kidney function long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

54 people

The number who actually took part.

Started

Aug 2021

Finished

May 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Patients ≥ 18 to ≤ 80 years (at date of signing the informed consent form \[ICF\]), but at least of legal age in the given country * Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF * Proteinuria at screening visit ≥ 1.0 g/d. * Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for ≥ 3 months prior to date of informed consent and adequate blood pressure (BP) control. * A female of childbearing potential (FCBP), is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of IMP Key Exclusion Criteria: * Hemoglobin \< 90 g/L * Thrombocytopenia: Platelets \< 100.0 x 10\^9/L. * Neutropenia: Neutrophils \< 1.5 x 10\^9/L. * Leukopenia: Leukocytes \< 3.0 x 10\^9/L * Diabetes mellitus type 1 * Aspartate aminotransferase or alanine aminotransferase \>1.5 x ULN, alkaline phosphatase \>3.0 x ULN

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Immunoglobulin A (IgA) nephropathy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis kidney disorder urinary system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Immunoglobulin A (IgA) nephropathy

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggido, 16499, South Korea

  • Amicis Research Center, Vacaville

    Vacaville, California, 95687, United States

  • CHU Sart Tilman Hospital

    Liège, 4000, Belgium

  • Clinical Centre of Vojvodina

    Novi Sad, Vojvodina, 21000, Serbia

  • Clinical Hospital Centar Zvezdara

    Belgrade, Serbia

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080, Serbia

  • Communal Nonprofit Enterprise "Kyiv City Center of Nephrology and Dialysis"

    Kyiv, Ukraine

  • Core Research Group

    Milton, Queensland, 4064, Australia

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, Sofia-Grad, 1680, Bulgaria

  • Eticka komise Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 775 20, Czechia

  • FOMAT Medical Research - FOMAT - HyperCore - PPDS

    Oxnard, California, 93030, United States

  • Fakultni nemocnice Kralovske Vinohrady Hospital

    Prague, Praha, Hlavní Mesto, 10034, Czechia

  • Far Eastern Memorial Hospital

    Taipei, 220, Taiwan

  • Fukushima Medical University Hospital

    Fukushima, Hukusima, 960-1295, Japan

  • Fundacio Puigvert

    Badalona, 8025, Spain

  • General Hospital Krusevac

    Kruševac, 37000, Serbia

  • Hokkaido University Hospital

    Sapporo, Hokkaidô, 060-8648, Japan

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Ruber Juan Bravo (Grupo Quironsalud)

    Madrid, Spain

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198, Spain

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, Spain

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 8916, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035, Spain

  • Hospital del Mar

    Barcelona, 8003, Spain

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu-Shi, Hukuoka, 807-8556, Japan

  • Imelda VZW

    Bonheiden, Antwerpen, Belgium

  • JCHO Sendai Hospital

    Sendai, Miyagi, 981-3205, Japan

  • JSC Evex Hospitals

    Tbilisi, 121, Georgia

  • Japanese Red Cross Ashikaga Hospital

    Ashikaga-Shi, Tochigi, 326-0843, Japan

  • Juntendo University Hospital

    Bunkyō-Ku, Tokyo, 113-8431, Japan

  • Konkuk University Medical Center

    Seoul, Seoul Teugbyeolsi, 5030, South Korea

  • Kurume University Hospital

    Kurume-Shi, Hukuoka, 830-0011, Japan

  • L. Managadze National Center of Urology LTD

    Tbilisi, 144, Georgia

  • Mayo Clinic Hospital - Methodist Campus

    Rochester, Minnesota, 55902, United States

  • MedResearch INC

    El Paso, Texas, 79935, United States

  • Medical Center Hera EOOD, Montana

    Montana, 3400, Bulgaria

  • Medical Center Hipokrat- N EOOD

    Plovdiv, 4000, Bulgaria

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Municipal Non-profit Enterprise Ternopil Regional Clinical Hospital of Ternopil Regional Council

    Ternopil, Ternopil Oblast, 46002, Ukraine

  • Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council

    Zaporizhzhia, 69600, Ukraine

  • National Hospital Organization Chibahigashi National Hospital

    Chiba, Chiba, 260-0801, Japan

  • Nemocnice AGEL Novy Jicin a.s

    Nový Jicín, Moravian-Silesian Region, 741 01, Czechia

  • Osaka University Hospital

    Suita-Shi, Ôsaka, 565-0871, Japan

  • Regionaal Ziekenhuis Jan Yperman VZW

    Ieper, Belgium

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggido, 13620, South Korea

  • St Frances Cabrini Medical Center and Cancer Institute

    Santo Tomas, Batangas, 4234, Philippines

  • State Institution Institute of Nephrology of NAMS of Ukraine

    Kyiv, Ukraine

  • Sunshine Hospital - Australia

    Saint Albans, Victoria, Australia

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • Tbilisi State Medical University's and Ingorokva's University Clinic of High Medical Technologies

    Tbilisi, 144, Georgia

  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    Uijeongbu-si, South Korea

  • UZ Leuven Hospital

    Leuven, Vlaams Brabant, 3000, Belgium

  • University Clinical Center Nis

    Niš, 18000, Serbia

  • University Malaya Medical Centre

    Pantai, Malaysia

  • University Multiprofile Hospital for Active Treatment

    Stara Zagora, Bulgaria

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45122, Germany

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Germany

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, Praha, Hlavní Mesto, 128 08, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.