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Monoclonal Antibodies

CFZ533 for Lupus Nephritis

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 1 (pre dose), day 15 (pre dose), day 29 (pre dose), day 57 (pre dose), day 85 (pre dose), day 113 (pre dose), day 141 (pre dose), day 169, day 197, day 225, day 253, day 281, day 309 and day 337 (end of study)

Summary

This trial tests a new medicine called CFZ533 for patients with kidney inflammation due to lupus. The medicine aims to block a protein that causes immune attacks on the kidneys, potentially reducing damage and inflammation.

Eligible Conditions
  • Lupus Nephritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 1 (pre dose), day 15 (pre dose), day 29 (pre dose), day 57 (pre dose), day 85 (pre dose), day 113 (pre dose), day 141 (pre dose), day 169, day 197, day 225, day 253, day 281, day 309 and day 337 (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 1 (pre dose), day 15 (pre dose), day 29 (pre dose), day 57 (pre dose), day 85 (pre dose), day 113 (pre dose), day 141 (pre dose), day 169, day 197, day 225, day 253, day 281, day 309 and day 337 (end of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Ratio to Baseline in Urinary Protein Creatinine Ratio (UPCR)
Secondary study objectives
Area Under Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of CFZ533
Change From Baseline in Urine Hyaline Casts
Hematuria Casts- Casts Granular
+7 more

Side effects data

From 2017 Phase 1 & 2 trial • 59 Patients • NCT02217410
41%
Constipation
38%
Leukopenia
38%
Hypertension
32%
Wound complication
32%
Hypophosphataemia
32%
Insomnia
29%
BK virus infection
29%
Nausea
29%
Nasopharyngitis
29%
Cough
26%
Hyperkalaemia
24%
Diarrhoea
24%
Vomiting
24%
Urinary tract infection
21%
Oedema peripheral
18%
Cytomegalovirus infection
18%
Incision site pain
18%
Hypokalaemia
18%
Muscle spasms
18%
Headache
15%
Abdominal pain upper
15%
Fatigue
15%
Postoperative wound complication
15%
Back pain
15%
Polyuria
15%
Kidney transplant rejection
12%
Polyomavirus-associated nephropathy
12%
Tachycardia
12%
Bronchitis
12%
Decreased appetite
12%
Hyperglycaemia
12%
Hyperuricaemia
12%
Hypocalcaemia
12%
Myalgia
9%
Anaemia
9%
Leukocytosis
9%
Abdominal pain
9%
Chills
9%
Complications of transplanted kidney
9%
Delayed graft function
9%
Procedural pain
9%
Amylase increased
9%
Blood creatinine increased
9%
White blood cell count increased
9%
Diabetes mellitus
9%
Hyponatraemia
9%
Tremor
9%
Bladder spasm
9%
Oropharyngeal pain
9%
Hyperhidrosis
9%
Groin pain
6%
Alopecia
6%
Gastroenteritis
6%
Retroperitoneal haematoma
6%
Pyelonephritis
6%
Lymphopenia
6%
Arrhythmia
6%
Atrial fibrillation
6%
Impaired healing
6%
Herpes zoster
6%
Influenza
6%
Pneumonia
6%
Respiratory tract infection
6%
Upper respiratory tract infection
6%
Transplant dysfunction
6%
Gamma-glutamyltransferase increased
6%
Lipase increased
6%
Weight increased
6%
Hypercalcaemia
6%
Hyperlipidaemia
6%
Vitamin D deficiency
6%
Arthralgia
6%
Pain in extremity
6%
Dizziness
6%
Perinephric collection
6%
Proteinuria
6%
Dyspnoea
6%
Dermatitis
6%
Night sweats
6%
Haematoma
6%
Hot flush
6%
Hypotension
6%
Poor venous access
6%
Human polyomavirus infection
6%
Transplant rejection
3%
Inguinal hernia
3%
Nasal congestion
3%
Vertigo
3%
Hyperparathyroidism
3%
Sinusitis
3%
Skin infection
3%
Muscular weakness
3%
Mental status changes
3%
Soft tissue infection
3%
Ligament sprain
3%
Paraesthesia oral
3%
Decubitus ulcer
3%
Hepatitis C
3%
Joint injury
3%
Menorrhagia
3%
Migraine
3%
Increased appetite
3%
Dry eye
3%
Prostatomegaly
3%
Acute kidney injury
3%
Diarrhoea haemorrhagic
3%
Gastrointestinal inflammation
3%
Pneumocystis jirovecii pneumonia
3%
Renal cyst infection
3%
Transplant failure
3%
Dehydration
3%
Squamous cell carcinoma
3%
Renal tubular necrosis
3%
Pneumothorax
3%
Hypertensive crisis
3%
Iron deficiency anaemia
3%
Microcytic anaemia
3%
Nephrogenic anaemia
3%
Neutropenia
3%
Thrombocytosis
3%
Angina pectoris
3%
Bradycardia
3%
Extrasystoles
3%
Myocardial infarction
3%
Palpitations
3%
Sinus tachycardia
3%
Ear discomfort
3%
Chalazion
3%
Ocular hyperaemia
3%
Retinal vein occlusion
3%
Abdominal discomfort
3%
Abdominal pain lower
3%
Aphthous ulcer
3%
Colitis
3%
Duodenogastric reflux
3%
Dyspepsia
3%
Flatulence
3%
Gastritis
3%
Haemorrhoids
3%
Cyst
3%
Infusion site swelling
3%
Pyrexia
3%
Swelling
3%
Hepatitis
3%
Acute sinusitis
3%
Cytomegalovirus viraemia
3%
Diarrhoea infectious
3%
Folliculitis
3%
Gastroenteritis Escherichia coli
3%
Gastrointestinal infection
3%
Oral candidiasis
3%
Oral herpes
3%
Oral infection
3%
Pharyngitis streptococcal
3%
Pyuria
3%
Subcutaneous abscess
3%
Tracheobronchitis
3%
Viral infection
3%
Wound infection bacterial
3%
Animal bite
3%
Arterial injury
3%
Fall
3%
Graft complication
3%
Incision site complication
3%
Lip injury
3%
Post procedural complication
3%
Post procedural haemorrhage
3%
Wound dehiscence
3%
Wound haematoma
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Blood creatine phosphokinase increased
3%
Blood glucose increased
3%
Blood phosphorus increased
3%
Electrocardiogram T wave abnormal
3%
Heart rate irregular
3%
Polyomavirus test positive
3%
Weight decreased
3%
White blood cell count decreased
3%
Dyslipidaemia
3%
Fluid overload
3%
Hypercholesterolaemia
3%
Hypertriglyceridaemia
3%
Metabolic acidosis
3%
Bursitis
3%
Joint effusion
3%
Musculoskeletal discomfort
3%
Neck pain
3%
Osteochondrosis
3%
Pain in jaw
3%
Basal cell carcinoma
3%
Ataxia
3%
Polyneuropathy
3%
Anxiety
3%
Delirium
3%
Mood swings
3%
Dysuria
3%
Haematuria
3%
Leukocyturia
3%
Nocturia
3%
Tubulointerstitial nephritis
3%
Urethral pain
3%
Urinary incontinence
3%
Urinary tract disorder
3%
Erectile dysfunction
3%
Scrotal swelling
3%
Vulvovaginal pain
3%
Dyspnoea exertional
3%
Lung infiltration
3%
Pleural effusion
3%
Productive cough
3%
Respiratory distress
3%
Rhinorrhoea
3%
Lipohypertrophy
3%
Pruritus
3%
Skin lesion
3%
Urticaria
3%
Lymphocele
3%
Infection
3%
Laryngitis
3%
Bacteraemia
3%
Enterobacter bacteraemia
3%
Otitis media
3%
Mouth ulceration
3%
Magnesium deficiency
3%
Arthropod bite
3%
Cytomegalovirus test positive
3%
Haemoglobin decreased
3%
Flank pain
3%
Burning sensation
3%
Penile oedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
CFZ533 + MMF (Part 2)
Total
CFZ533 + TAC + MMF (Part 1)
Tac + MMF (Part 2)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CFZ533Experimental Treatment1 Intervention
Investigational drug CFZ533 will be administred as multiple doses
Group II: PlaceboPlacebo Group1 Intervention
Investigational drug matching placebo will be administered as multiple doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CFZ533
2019
Completed Phase 2
~570

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,620 Total Patients Enrolled
8 Trials studying Lupus Nephritis
1,287 Patients Enrolled for Lupus Nephritis
~8 spots leftby Nov 2025
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