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New drug shows promise in preventing kidney transplant rejection

NCT ID NCT03663335

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called CFZ533 in 418 kidney transplant patients to see if it could prevent organ rejection as well as the standard drug tacrolimus. Patients received either CFZ533 or tacrolimus along with other standard medications. The main goal was to compare rates of rejection, graft loss, or death over 12 months. Results will help determine if CFZ533 is a safe and effective alternative for transplant patients.

What this could mean

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

Active substance
CFZ533 (an anti-CD40 monoclonal antibody)
What this could lead to
If successful, CFZ533 could offer a new option to prevent kidney transplant rejection, potentially with fewer side effects than current standard treatments.
What could go wrong
This is a phase 2 trial, so results are preliminary. The drug may not prove superior or safer than existing therapies in larger studies. Risks include infection and rejection.

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

418 people

The number who actually took part.

Started

Nov 2018

Finished

Oct 2021

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 years and older

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.

Inclusion Criteria: Key inclusion criteria for both cohorts * Written informed consent obtained before any assessment. * Male or female patient ≥ 18 years old. * Up to date vaccination as per local immunization schedules. Key inclusion criteria specific to Cohort 1: * Recipients of a primary kidney transplant from a brain-dead donor, living unrelated or non-human leukocyte antigen (HLA) identical living related donors. * Recipients of a kidney with a cold ischemia time \< 24 hours. Key inclusion criteria specific to Cohort 2: * Recipients of a primary graft received 6 to 24 months prior enrollment, on a regimen containing TAC+MMF/ Enteric-coated mycophenolate sodium (EC-MPS)±corticosteroids (CS). * Patients with an actual eGFR according to Modification of Diet in Renal Disease (MDRD-4) ≥ 45 mL/min/1.73m2. Exclusion Criteria: Key exclusion criteria for both cohorts * Recipient who tests positive for anti-HIV, HBsAg or anti-HCV (without proof of sustained viral response (SVR12) after anti-HCV treatment) within 28 days prior to baseline visit. * Recipient who tests negative for Epstein Barr virus (EBV) within 28 days prior to baseline visit. * Evidence of advanced liver disease (Child-Pugh C), or any sign of liver decompensation. * Patient with severe systemic infections, current or within the two weeks prior to randomization. * History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions. * Patients who weighed less than 30 kg or more than 180 kg. Key exclusion criteria specific to Cohort 1: * Multi-organ transplant recipients, including en bloc and dual kidney transplantation, or prior kidney transplant * Recipients of an organ from a donor after cardiac death. * Recipient of an organ from an HLA identical living related donor. * ABO incompatible or complement-dependent lymphocytotoxic crossmatch positive transplant (isolated positive B cell crossmatches were not an exclusion criterion). * Recipients of kidneys from donors who were older than \>65 years. * Recipients of kidneys from donors with terminal serum creatinine \> 2 mg/dL. * Patients at high immunological risk for rejection as determined for assessment of anti-donor reactivity: * high panel reactive antibodies\> 20% or * Presence of pre-formed DSA. Results 12 weeks prior to enrollment were acceptable if no blood transfusion or abortion occurred during this period. * Recipient of a kidney from a donor who tests positive for HIV, HBsAg or HCV. Key exclusion criteria to Cohort 2 * Recipients of a kidney re-transplant. * Recipient of a multi-organ transplant, including en bloc and dual kidney transplantation. * DSA within 12 weeks prior enrollment. * eGFR decline ≥10.0 mL/min within 12 weeks prior enrollment. * Ongoing rejection or rejection that required treatment within 12 weeks prior enrollment. * Severe humoral and/or cellular rejection (BANFF ≥ IIb) within 12 weeks before enrollment. * Proteinuria \> 1 g/day or UPCR \>1.2 mg/mg at time of enrollment

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Conditions

The condition(s) this trial relates to.

transplant rejection prevention target

As listed by the trial registrant

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

Kidney transplantation

Contacts and locations

Locations

  • Novartis Investigative Site

    Los Angeles, California, 90033, United States

  • Novartis Investigative Site

    San Francisco, California, 94143 0116, United States

  • Novartis Investigative Site

    Aurora, Colorado, 80045, United States

  • Novartis Investigative Site

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    Chicago, Illinois, 60612, United States

  • Novartis Investigative Site

    Kansas City, Kansas, 66103, United States

  • Novartis Investigative Site

    Baltimore, Maryland, 21201, United States

  • Novartis Investigative Site

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    Detroit, Michigan, 48202 2689, United States

  • Novartis Investigative Site

    St Louis, Missouri, 63110, United States

  • Novartis Investigative Site

    Durham, North Carolina, 27710, United States

  • Novartis Investigative Site

    Cincinnati, Ohio, 45219, United States

  • Novartis Investigative Site

    Cincinnati, Ohio, 45267-0585, United States

  • Novartis Investigative Site

    Dallas, Texas, 75390, United States

  • Novartis Investigative Site

    Seattle, Washington, 98195, United States

  • Novartis Investigative Site

    Buenos Aires, W3400ABH, Argentina

  • Novartis Investigative Site

    Corrientes, W3400, Argentina

  • Novartis Investigative Site

    Córdoba, X5016KEH, Argentina

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050, Australia

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04038-002, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403 000, Brazil

  • Novartis Investigative Site

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Novartis Investigative Site

    Prague, 146 24, Czechia

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Créteil, 94010, France

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Lyon, 69003, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75015, France

  • Novartis Investigative Site

    Toulouse, 31054, France

  • Novartis Investigative Site

    Tours, 37044, France

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Dresden, 01307, Germany

  • Novartis Investigative Site

    Erlangen, 91054, Germany

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    Mainz, 55131, Germany

  • Novartis Investigative Site

    Budapest, H-1083, Hungary

  • Novartis Investigative Site

    Debrecen, 4032, Hungary

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Nagakute, Aichi-ken, 480-1195, Japan

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466-8650, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060 8648, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-8604, Japan

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232 0024, Japan

  • Novartis Investigative Site

    Tomigusuku, Okinawa, 9010224, Japan

  • Novartis Investigative Site

    Suita, Osaka, 565 0871, Japan

  • Novartis Investigative Site

    Kumamoto, 861-8520, Japan

  • Novartis Investigative Site

    Osaka, 545-8586, Japan

  • Novartis Investigative Site

    Riga, LV 1002, Latvia

  • Novartis Investigative Site

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Novartis Investigative Site

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Utrecht, 3584CX, Netherlands

  • Novartis Investigative Site

    Oslo, 0424, Norway

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07120, Spain

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036, Spain

  • Novartis Investigative Site

    Zaragoza, 50009, Spain

  • Novartis Investigative Site

    Gothenburg, 413 45, Sweden

  • Novartis Investigative Site

    Uppsala, 751 85, Sweden

  • Novartis Investigative Site

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    Glasgow, G51 4TF, United Kingdom

  • Novartis Investigative Site

    London, SW17 0QT, United Kingdom

  • Novartis Investigative Site

    Manchester, M13 9WL, United Kingdom

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