18 and older, any sex, with Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Cmax Pharmacokinetic Parameter- Part IPrimary· Day 1
Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I
Group
Value
95% CI
CFZ533 + TAC + MMF (Part 1)
66.3
± 12.3
Mean Tmax Pharmacokinetic Parameter - Part IPrimary· Day 1
Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.
Group
Value
95% CI
CFZ533 + TAC + MMF (Part 1)
0.237
0 – 1.02
Mean AUClast Pharmacokinetic Parameter - Part IPrimary· Day 1
Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.
Group
Value
95% CI
CFZ533 + TAC + MMF (Part 1)
367
± 52.0
Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part IIPrimary· 3, 6, 9, and 12 months
To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale.
An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy.
Month 3
Group
Value
95% CI
CFZ533 + MMF (Part 2)
6
Tac + MMF (Part 2)
2
Month 6
Group
Value
95% CI
CFZ533 + MMF (Part 2)
7
Tac + MMF (Part 2)
3
Month 9
Group
Value
95% CI
CFZ533 + MMF (Part 2)
7
Tac + MMF (Part 2)
3
Month 12
Group
Value
95% CI
CFZ533 + MMF (Part 2)
7
Tac + MMF (Part 2)
3
Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1Secondary· Baseline to end of study (Day 1, Day 29, Day 337)
To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154
Baseline
Group
Value
95% CI
sCD40 (Part I)
4.03
± 4.08
sCD154
0.125
± 0.007
Day 1
Group
Value
95% CI
sCD40 (Part I)
8.86
± 0.0585
sCD154
0.0585
± 0.0711
Day 2
Group
Value
95% CI
sCD40 (Part I)
16.7
± 4.51
sCD154
0.139
± 0.193
Day 3
Group
Value
95% CI
sCD40 (Part I)
24.8
± 4.47
sCD154
0.157
± 0.235
Day 4
Group
Value
95% CI
sCD40 (Part I)
31.3
± 6.34
sCD154
0.241
± 0.418
Day 8
Group
Value
95% CI
sCD40 (Part I)
54.0
± 11.2
sCD154
0.399
± 0.636
Day 15
Group
Value
95% CI
sCD40 (Part I)
84.1
± 13.8
sCD154
0.0879
± 0.139
Day 22
Group
Value
95% CI
sCD40 (Part I)
102
± 13.9
sCD154
0.0500
± 0.132
Free CD40 and Total CD40 on B Cells - Part IISecondary· Baseline to end of study (Day 1/predose)
The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome
CFZ553 + MMF (Baseline)
Group
Value
95% CI
Free CD40 on Whole Blood B Ceels
30836.00
± 13648.69
Total CD40 on Whole Blood B Cells
12778.80
± 7873.76
CFZ553 + MMF (D1 - 6h post dose)
Group
Value
95% CI
Free CD40 on Whole Blood B Ceels
1623.81
± 1359.85
Total CD40 on Whole Blood B Cells
13806.90
± 7185.66
CFZ553 + MMF (D15)
Group
Value
95% CI
Free CD40 on Whole Blood B Ceels
799.62
± 762.38
Total CD40 on Whole Blood B Cells
15160.38
± 7398.57
CFZ553 + MMF (D 29)
Group
Value
95% CI
Free CD40 on Whole Blood B Ceels
817.63
± 1540.16
Total CD40 on Whole Blood B Cells
13299.60
± 6330.89
CFZ553 + MMF (D 57)
Group
Value
95% CI
Free CD40 on Whole Blood B Ceels
597.13
± 523.55
Total CD40 on Whole Blood B Cells
12234.38
± 6943.13
CFZ553 + MMF (D 85)
Group
Value
95% CI
Free CD40 on Whole Blood B Ceels
635.47
± 614.68
Total CD40 on Whole Blood B Cells
9330.86
± 8484.46
CFZ553 + MMF (D 197)
Group
Value
95% CI
Free CD40 on Whole Blood B Ceels
3699.0
± 7298.98
Total CD40 on Whole Blood B Cells
2820.72
± 2347.11
CFZ553 + MMF (253)
Group
Value
95% CI
Free CD40 on Whole Blood B Ceels
2667.38
± 6146.86
Total CD40 on Whole Blood B Cells
1427.14
± 740.48
Anti-CFZ533 Antibodies - Part ISecondary· Baseline to end of study
To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies
Group
Value
95% CI
CFZ533 + TAC + MMF (Part 1)
0
Anti-CFZ533 Antibodies - Part IISecondary· Baseline to end of study (screening, baseline, Day 141, Day 225, Day 309, Study Completion)
To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies
Screening
Group
Value
95% CI
CFZ533 + MMF (Part 2)
0
Tac + MMF (Part 2)
0
Baseline
Group
Value
95% CI
CFZ533 + MMF (Part 2)
0
Day 141
Group
Value
95% CI
CFZ533 + MMF (Part 2)
0
Tac + MMF (Part 2)
0
Day 225
Group
Value
95% CI
CFZ533 + MMF (Part 2)
0
Tac + MMF (Part 2)
0
Day 309
Group
Value
95% CI
CFZ533 + MMF (Part 2)
0
Tac + MMF (Part 2)
0
Study Completion
Group
Value
95% CI
CFZ533 + MMF (Part 2)
0
Tac + MMF (Part 2)
0
eGFR - Part IISecondary· Day 1, Day 29, Day 337,
Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula.
eGFR: Estimated glomerular filtration rate
Day 1
Group
Value
95% CI
CFZ533 + MMF (Part 2)
9.8
8.3 – 11.3
Tac + MMF (Part 2)
9.7
7.7 – 11.8
Day 29
Group
Value
95% CI
CFZ533 + MMF (Part 2)
55.6
50.4 – 60.7
Tac + MMF (Part 2)
44.3
37.2 – 51.4
Day 337
Group
Value
95% CI
CFZ533 + MMF (Part 2)
58.2
52.2 – 64.2
Tac + MMF (Part 2)
44.2
36.1 – 52.3
CFZ533 Plasma PK Concentrations - Part IISecondary· throughout study period (day 84 to day 336)
Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen.
Day 84
Group
Value
95% CI
CFZ533 + MMF (Part 2)
247
± 58.2
Day 112
Group
Value
95% CI
CFZ533 + MMF (Part 2)
211
± 51.8
Day 140
Group
Value
95% CI
CFZ533 + MMF (Part 2)
178
± 54.9
Day 168
Group
Value
95% CI
CFZ533 + MMF (Part 2)
157
± 57.4
Day 196
Group
Value
95% CI
CFZ533 + MMF (Part 2)
148
± 53.1
Day 224
Group
Value
95% CI
CFZ533 + MMF (Part 2)
147
± 53.8
Day 252
Group
Value
95% CI
CFZ533 + MMF (Part 2)
151
± 35.2
Day 280
Group
Value
95% CI
CFZ533 + MMF (Part 2)
160
± 87.7
Total sCD40 Plasma Concentrations - Part IISecondary· 12 months
To quantify the change from baseline and recovery of peripheral blood total soluble CD40
Baseline
Group
Value
95% CI
CFZ533 + MMF (Part 2)
3.02
± 2.44
Tac + MMF (Part 2)
3.67
± 2.15
Day 1
Group
Value
95% CI
CFZ533 + MMF (Part 2)
6.95
± 4.29
Tac + MMF (Part 2)
1.16
± 1.15
Day 4
Group
Value
95% CI
CFZ533 + MMF (Part 2)
24.6
± 11.0
Tac + MMF (Part 2)
1.16
± 1.15
Day 15
Group
Value
95% CI
CFZ533 + MMF (Part 2)
69.6
± 21.5
Tac + MMF (Part 2)
0.869
± 1.55
Day 29
Group
Value
95% CI
CFZ533 + MMF (Part 2)
101
± 18.9
Tac + MMF (Part 2)
0.362
± 0.0746
Day 57
Group
Value
95% CI
CFZ533 + MMF (Part 2)
140
± 17.4
Tac + MMF (Part 2)
0.438
± 0.316
Day 85
Group
Value
95% CI
CFZ533 + MMF (Part 2)
189
± 76.4
Tac + MMF (Part 2)
0.429
± 0.324
Day 113
Group
Value
95% CI
CFZ533 + MMF (Part 2)
215
± 75.5
Tac + MMF (Part 2)
0.391
± 0.129
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 3 years..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CFZ533 + TAC + MMF (Part 1)
Serious: 4/7 (57%)
Deaths: 0/7
CFZ533 + MMF (Part 2)
Serious: 21/34 (62%)
Deaths: 0/34
Tac + MMF (Part 2)
Serious: 12/18 (67%)
Deaths: 0/18
Total
Serious: 37/59 (63%)
Deaths: 0/59
Serious adverse events (59 terms)
Reaction
System
CFZ533 + TAC + MMF (Part 1)
CFZ533 + MMF (Part 2)
Tac + MMF (Part 2)
Total
Kidney transplant rejection
Immune system disorders
—
—
—
—
Cytomegalovirus infection
Infections and infestations
—
—
—
—
Polyomavirus-associated nephropathy
Infections and infestations
—
—
—
—
Pyelonephritis
Infections and infestations
—
—
—
—
Complications of transplanted kidney
Injury, poisoning and procedural complications
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
Retroperitoneal haematoma
Gastrointestinal disorders
—
—
—
—
Transplant rejection
Immune system disorders
—
—
—
—
Urosepsis
Infections and infestations
—
—
—
—
Graft loss
Injury, poisoning and procedural complications
—
—
—
—
Transplant dysfunction
Injury, poisoning and procedural complications
—
—
—
—
Blood creatinine increased
Investigations
—
—
—
—
Headache
Nervous system disorders
—
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
—
Leukopenia
Blood and lymphatic system disorders
—
—
—
—
Pancytopenia
Blood and lymphatic system disorders
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
Tricuspid valve incompetence
Cardiac disorders
—
—
—
—
Photophobia
Eye disorders
—
—
—
—
Vision blurred
Eye disorders
—
—
—
—
Diarrhoea haemorrhagic
Gastrointestinal disorders
—
—
—
—
Gastrointestinal inflammation
Gastrointestinal disorders
—
—
—
—
Inguinal hernia
Gastrointestinal disorders
—
—
—
—
Other adverse events (307 terms — click to expand)
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04129528 — Study of Safety and Efficacy of CFZ533 in Type 1 Diabetes Pediatric and Young Adult Subjects
· Phase 2
· completed
NCT03781414 — Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibo
· Phase 2
· terminated
NCT03905525 — Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome
· Phase 2
· completed
NCT03827798 — Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 2
· active not recruiting
NCT03656562 — Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients
· Phase 2
· completed
Other recruiting trials for Kidney Transplantation
Currently open trials in the same condition.
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· Phase 1, PHASE2
· recruiting
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· Phase 4
· recruiting
NCT06829719 — TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation
· NA
· recruiting
NCT07316829 — TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Re
· active not recruiting
NCT06886256 — Prehabilitation for Kidney Transplant Candidates
· NA
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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· Phase 3
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· Phase 4
· not yet recruiting
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· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 28 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02217410.