Kidney TransplantationPhase 2CIRRUS INCT03663335
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
A Phase 2 study testing CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF) and Corticosteroids (CS) in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 74 sites in 20 countries.
Trial summary
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF) and Corticosteroids (CS)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 418 participants
- Where
- 74 sitesin 20 countries
- Study dates
- 28 Nov 2018to 29 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained before any assessment.
- Male or female patient ≥ 18 years old.
- Up to date vaccination as per local immunization schedules.
- 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.
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
- 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
Trial locations and contacts
74 sites in 20 countries.
74 sites in 20 countries
United States15 sites
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Baltimore, Maryland, 21201
Novartis Investigative Site
Boston, Massachusetts, 02114
Novartis Investigative Site
Chicago, Illinois, 60611
Novartis Investigative Site
Chicago, Illinois, 60612
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Cincinnati, Ohio, 45267-0585
Novartis Investigative Site
Dallas, Texas, 75390
Novartis Investigative Site
Detroit, Michigan, 48202 2689
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Kansas City, Kansas, 66103
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
San Francisco, California, 94143 0116
Novartis Investigative Site
Seattle, Washington, 98195
Novartis Investigative Site
St Louis, Missouri, 63110
Japan9 sites
Novartis Investigative Site
Kumamoto, 861-8520
Novartis Investigative Site
Nagakute, Aichi-ken, 480-1195
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8650
Novartis Investigative Site
Osaka, 545-8586
Novartis Investigative Site
Sapporo, Hokkaido, 060 8648
Novartis Investigative Site
Sapporo, Hokkaido, 060-8604
Novartis Investigative Site
Suita, Osaka, 565 0871
Novartis Investigative Site
Tomigusuku, Okinawa, 9010224
Novartis Investigative Site
Yokohama, Kanagawa, 232 0024
France8 sites
Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Créteil, 94010
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Lyon, 69003
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Toulouse, 31054
Novartis Investigative Site
Tours, 37044
Germany8 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Regensburg, Bavaria, 93053
Spain6 sites
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, 08907
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, 07120
Novartis Investigative Site
Zaragoza, 50009
Argentina3 sites
Novartis Investigative Site
Buenos Aires, W3400ABH
Novartis Investigative Site
Córdoba, X5016KEH
Novartis Investigative Site
Corrientes, W3400
Australia3 sites
Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Clayton, Victoria, 3168
Brazil3 sites
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90020-090
Novartis Investigative Site
São Paulo, São Paulo, 04038-002
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
Netherlands3 sites
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Rotterdam, South Holland, 3015 GD
Novartis Investigative Site
Utrecht, 3584CX
United Kingdom3 sites
Novartis Investigative Site
Glasgow, G51 4TF
Novartis Investigative Site
London, SW17 0QT
Novartis Investigative Site
Manchester, M13 9WL
Hungary2 sites
Novartis Investigative Site
Budapest, H-1083
Novartis Investigative Site
Debrecen, 4032
Italy2 sites
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Roma, RM, 00133
Sweden2 sites
Novartis Investigative Site
Gothenburg, 413 45
Novartis Investigative Site
Uppsala, 751 85
About this study
Official title: A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
Read the detailed description
The purpose of this study was to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients.
Study CCFZ533A2201 was a randomized, planned 60-month (5 year) study comprising of 12-months treatment for the primary analysis plus an additional 48-month treatment period. The study had 2 different cohorts: adult de novo kidney transplant recipients and maintenance kidney transplant population (6-24 months post-transplant).
The study was terminated after the interim analysis.
- Conditions
- Kidney Transplantation
- Being tested
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS), Tacrolimus, Induction therapy: basiliximab
- Keywords
- Kidney Transplant Rejection, Renal transplantation, CFZ533, CNI-free immunosuppression, transplant rejection, allograft rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFZ533 - Cohort 1/Cohort 2Biological
CFZ533 was administered either by intravenous infusion or subcutaneous injection
Mycophenolate Mofetil (MMF)Drug
Per local practice, 250 mg or 500 mg taken orally or 500 mg taken intravenously.
Corticosteroids (CS)Drug
Taken either orally or intravenously.
TacrolimusDrug
Standard of care immunosuppressive regimen
Induction therapy: basiliximabDrug
Lyophilized solution taken intravenously
Induction therapy: rabbit anti-thymocyte globulin (rATG)Drug
Also called Lyophilized solution
Lyophilized vial taken intravenously.
Maintenance population: EC-MPSDrug
Tablet that is taken orally
Maintenance population: MMFDrug
Tablet that is taken orally
Placebo 1 mLDrug
Solution taken subcutaneously and was used for blinding of the CFZ533 doses.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids | Experimental | Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit. Receives: Biological: CFZ533 - Cohort 1/Cohort 2; Drug: Mycophenolate Mofetil (MMF); Drug: Corticosteroids (CS); Drug: Induction therapy: basiliximab; Drug: Induction therapy: rabbit anti-thymocyte globulin (rATG) |
| Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids | Experimental | Eligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids.
Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant.
Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit. Receives: Biological: CFZ533 - Cohort 1/Cohort 2; Drug: Mycophenolate Mofetil (MMF); Drug: Corticosteroids (CS); Drug: Induction therapy: basiliximab; Drug: Induction therapy: rabbit anti-thymocyte globulin (rATG); Drug: Placebo 1 mL |
| Arm 3/Cohort 1: Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids | Active comparator | Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids. Receives: Drug: Mycophenolate Mofetil (MMF); Drug: Corticosteroids (CS); Drug: Tacrolimus; Drug: Induction therapy: basiliximab; Drug: Induction therapy: rabbit anti-thymocyte globulin (rATG) |
| Arm 1/Cohort 2: CFZ533 450 mg + MMF ± Corticosteroids | Experimental | Eligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W.
On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose.
At Day 15, CFZ533 were administered sc at 450 mg (1 injection of 2 mL \& 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit. Receives: Biological: CFZ533 - Cohort 1/Cohort 2; Drug: Corticosteroids (CS); Drug: Maintenance population: EC-MPS; Drug: Maintenance population: MMF |
| Arm 2/Cohort 2: TAC + MMF ± Corticosteroids | Active comparator | Patients received TAC-based regimen throughout the study. Receives: Drug: Corticosteroids (CS); Drug: Tacrolimus; Drug: Maintenance population: EC-MPS; Drug: Maintenance population: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1)
The composite efficacy failure event is defined as any of the following:
(1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.
Measured: 12 Months
Percentage of Participants With Composite Efficacy Failure Event (BPAR, Graft Loss or Death) Over 12 Months Post-conversion (Cohort 2)
The composite efficacy failure event is defined as any of the following:
(1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.
Measured: 12 Months
Secondary outcomes (6)
Cohort 1: Mean Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-transplantation
In the de novo population (Cohort 1), the mean eGFR at Month 12 post-transplantation was the endpoint of interest. Estimated GFR using central laboratory serum creatinine values was calculated using the MDRD4 formula.
Measured: 12 months
Cohort 2: Mean Change in Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-conversion
In the maintenance population (Cohort 2), a baseline kidney function and the mean change from baseline at Month 12 post-conversion of eGFR was the endpoint of interest. Estimated GFR using central laboratory serum creatinine values was calculated using the MDRD4 formula.
Measured: 12 months
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Pharmacokinetics were determined for free CFZ533 plasma concentrations during the treatment period.
Measured: Day 1-Pre-Dose to Month 30-Pre-Dose
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Pharmacokinetics were determined for free CFZ533 plasma concentrations during the treatment period.
Measured: Day 1-Pre-Dose to Month 30-Pre-Dose
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
The presence of anti-CFZ533 antibodies was assessed using screening and confirmatory assays.
Measured: 24 Months
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
The presence of anti-CFZ533 antibodies was assessed using screening and confirmatory assays.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start28 Nov 2018
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663335
- Sponsor's protocol ID
- CCFZ533A2201
- Other IDs
- 2017-003607-22, 2017
- Acronym
- CIRRUS I
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2018
- Last updated
- 23 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)
- ClinicalTrials.gov ID
- NCT03663335
- Acronym / sponsor ID
- CIRRUS I / CCFZ533A2201
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplant Rejection, Renal transplantation, CFZ533, CNI-free immunosuppression, transplant rejection, allograft rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Posted 23 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
Detailed description
The purpose of this study was to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients.
Study CCFZ533A2201 was a randomized, planned 60-month (5 year) study comprising of 12-months treatment for the primary analysis plus an additional 48-month treatment period. The study had 2 different cohorts: adult de novo kidney transplant recipients and maintenance kidney transplant population (6-24 months post-transplant).
The study was terminated after the interim analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids | Experimental | Biological: CFZ533 - Cohort 1/Cohort 2, Drug: Mycophenolate Mofetil (MMF), Drug: Corticosteroids (CS), Drug: Induction therapy: basiliximab, Drug: Induction therapy: rabbit anti-thymocyte globulin (rATG)Eligible patients were randomized to CFZ533 600 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 600 mg sc (2 injections of 2 mL CFZ533 at 150 mg/mL) Q2W, up to a planned Month 59.5 visit. |
| Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids | Experimental | Biological: CFZ533 - Cohort 1/Cohort 2, Drug: Mycophenolate Mofetil (MMF), Drug: Corticosteroids (CS), Drug: Induction therapy: basiliximab, Drug: Induction therapy: rabbit anti-thymocyte globulin (rATG), Drug: Placebo 1 mLEligible patients were randomized to CFZ533 300 mg sc bi-weekly (Q2W) + Mycophenolate Mofetil (MMF) + Corticosteroids. Patients randomized to CFZ533 arms were administered the first dose of CFZ533 at 30 mg/kg IV pre- or intra-operatively (Day 1) with completion of the infusion within one hour of unclamping and prior graft revascularization, in combination with MMF and corticosteroids. MMF and corticosteroids might be initiated prior to surgery according to local practice. A second IV dose of CFZ533 at 15 mg/kg was infused at Day 5 post-transplant. Subsequent doses starting at Day 15: 300 mg sc (1 injection of 2 mL CFZ533 at 150 mg/mL, and 1 injection of 2 mL of the generic placebo) sc, Q2W, up to a planned Month 59.5 visit. |
| Arm 3/Cohort 1: Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids | Active comparator | Drug: Mycophenolate Mofetil (MMF), Drug: Corticosteroids (CS), Drug: Tacrolimus, Drug: Induction therapy: basiliximab, Drug: Induction therapy: rabbit anti-thymocyte globulin (rATG)Patients randomized to the TAC control arm were initiated on a TAC-based regimen with MMF and corticosteroids. |
| Arm 1/Cohort 2: CFZ533 450 mg + MMF ± Corticosteroids | Experimental | Biological: CFZ533 - Cohort 1/Cohort 2, Drug: Corticosteroids (CS), Drug: Maintenance population: EC-MPS, Drug: Maintenance population: MMFEligible patients who were 6 to 24 months post renal transplantation and were on a stable regimen containing TAC+MMF/Enteric-coated mycophenolate sodium (EC-MPS)±CS were randomized to CFZ533 450 mg sc Q2W. On Day 1, patients randomized to Arm 1 were administered the 1st dose of CFZ533 at 30 mg/kg IV, concomitantly with MMF/EC-MPS and 50% of the current TAC dose. At Day 15, CFZ533 were administered sc at 450 mg (1 injection of 2 mL \& 1 injection of 1 mL CFZ533 at 150 mg/mL) concomitantly with MMF/EC-MPS, and TAC reduced by a further 50%. By Day 29, patients were fully tapered off their TAC. Subsequent doses of 450 mg sc Q2W, were administered in combination with MMF/EC-MPS with or without corticosteroids, up to Month 59.5 visit. |
| Arm 2/Cohort 2: TAC + MMF ± Corticosteroids | Active comparator | Drug: Corticosteroids (CS), Drug: Tacrolimus, Drug: Maintenance population: EC-MPS, Drug: Maintenance population: MMFPatients received TAC-based regimen throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent obtained before any assessment.
- Male or female patient ≥ 18 years old.
- Up to date vaccination as per local immunization schedules.
- 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 exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFZ533 - Cohort 1/Cohort 2CFZ533 was administered either by intravenous infusion or subcutaneous injection | Biological | Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 1/Cohort 2: CFZ533 450 mg + MMF ± Corticosteroids, Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids |
| Mycophenolate Mofetil (MMF)Per local practice, 250 mg or 500 mg taken orally or 500 mg taken intravenously. | Drug | Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 3/Cohort 1: Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids |
| Corticosteroids (CS)Taken either orally or intravenously. | Drug | Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 1/Cohort 2: CFZ533 450 mg + MMF ± Corticosteroids, Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 2/Cohort 2: TAC + MMF ± Corticosteroids, Arm 3/Cohort 1: Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids |
| TacrolimusStandard of care immunosuppressive regimen | Drug | Arm 2/Cohort 2: TAC + MMF ± Corticosteroids, Arm 3/Cohort 1: Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids |
| Induction therapy: basiliximabLyophilized solution taken intravenously | Drug | Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 3/Cohort 1: Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids |
| Induction therapy: rabbit anti-thymocyte globulin (rATG)Also: Lyophilized solutionLyophilized vial taken intravenously. | Drug | Arm 1/Cohort 1: CFZ533 600 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids, Arm 3/Cohort 1: Control/Standard of Care: Tacrolimus (TAC) + MMF + Corticosteroids |
| Maintenance population: EC-MPSTablet that is taken orally | Drug | Arm 1/Cohort 2: CFZ533 450 mg + MMF ± Corticosteroids, Arm 2/Cohort 2: TAC + MMF ± Corticosteroids |
| Maintenance population: MMFTablet that is taken orally | Drug | Arm 1/Cohort 2: CFZ533 450 mg + MMF ± Corticosteroids, Arm 2/Cohort 2: TAC + MMF ± Corticosteroids |
| Placebo 1 mLSolution taken subcutaneously and was used for blinding of the CFZ533 doses. | Drug | Arm 2/Cohort 1: CFZ533 300 mg + Mycophenolate Mofetil (MMF) + Corticosteroids |
Primary outcome
Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1)
Time frame: 12 Months
The composite efficacy failure event is defined as any of the following: (1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.
Percentage of Participants With Composite Efficacy Failure Event (BPAR, Graft Loss or Death) Over 12 Months Post-conversion (Cohort 2)
Time frame: 12 Months
The composite efficacy failure event is defined as any of the following: (1) biopsy-proven acute rejection (BPAR) or (2) graft loss or (3) death. BPAR (BANFF ≥ 1A) is based on the central and adjudicated assessments. Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis or re-transplanted. If the participant underwent allograft nephrectomy prior to start of permanent dialysis, the day of the nephrectomy was day of graft loss.
6 secondary outcomes
Cohort 1: Mean Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-transplantation
Time frame: 12 months
Cohort 2: Mean Change in Estimated Glomerular Filtration Rate (eGFR) ((MDRD4) at 12 Months Post-conversion
Time frame: 12 months
Free CFZ533 Plasma Concentrations Over Time (Cohort 1)
Time frame: Day 1-Pre-Dose to Month 30-Pre-Dose
Free CFZ533 Plasma Concentrations Over Time (Cohort 2)
Time frame: Day 1-Pre-Dose to Month 30-Pre-Dose
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 1)
Time frame: 24 Months
Semi-quantiative Analysis of Anti-CFZ533 Antibodes in Plasma (CFZ533 Treated Patients Only) (Cohort 2)
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
74 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF) and Corticosteroids (CS) in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 74 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Japan, France, Germany, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Composite Efficacy Failure Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months Post-transplantation (Cohort 1) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.