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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 from baseline to week 49, pre dose and 1 hour post dose
Awards & highlights
Study Summary
This trial is testing a new drug to treat lupus nephritis, to see if it is safe and effective.
Eligible Conditions
- Lupus Nephritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 49, pre dose and 1 hour post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 49, pre dose and 1 hour post dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Renal proteinuria
Safety as assessed by adverse events
Secondary outcome measures
Complete renal remission
Immunogenicity of CFZ533
Plasma pharmacokinetics (PK) of CFZ533 The lowest plasma concentration observed during a dosing interval at steady state (Cmin,ss)
+5 moreSide effects data
From 2017 Phase 1 & 2 trial • 59 Patients • NCT0221741056%
Diarrhoea
50%
Nausea
44%
Wound complication
44%
Constipation
39%
Urinary tract infection
33%
Hypertension
33%
Procedural pain
33%
BK virus infection
33%
Oedema peripheral
33%
Tremor
28%
Hyperkalaemia
28%
Hypokalaemia
28%
Insomnia
28%
Fatigue
28%
Hypophosphataemia
22%
Vomiting
22%
Hyperglycaemia
22%
Nasopharyngitis
22%
Headache
22%
Anaemia
17%
Delayed graft function
17%
Transplant dysfunction
17%
Rash
17%
Hypotension
17%
Hypomagnesaemia
17%
Diabetes mellitus
17%
Dizziness
17%
Leukopenia
17%
Pyelonephritis
17%
Abdominal pain
17%
Dyspnoea
11%
Leukocytosis
11%
Catheter site pain
11%
Complications of transplanted kidney
11%
Cytomegalovirus infection
11%
Graft loss
11%
Hypercholesterolaemia
11%
Metabolic acidosis
11%
Haematuria
11%
Urinary incontinence
11%
Pruritus
11%
Pain in extremity
11%
Cough
11%
Incision site pain
11%
Renal tubular necrosis
11%
Alopecia
11%
Stomatitis
11%
Dysmenorrhoea
11%
Gingival swelling
11%
Haemorrhoids
11%
Neutropenia
11%
Flatulence
11%
Fungal skin infection
11%
Hypervolaemia
11%
Renal impairment
11%
Urosepsis
6%
Tongue discomfort
6%
Hyperuricaemia
6%
Dizziness postural
6%
Skin infection
6%
Peroneal nerve palsy
6%
Decreased appetite
6%
Incision site haemorrhage
6%
Hypercalcaemia
6%
Thrombocytopenia
6%
Acute kidney injury
6%
Hepatic function abnormal
6%
Drug hypersensitivity
6%
Pelvic venous thrombosis
6%
Iron deficiency anaemia
6%
Atrial fibrillation
6%
Arteriovenous fistula aneurysm
6%
Incisional hernia
6%
Gastrointestinal infection
6%
Impaired healing
6%
Polyomavirus-associated nephropathy
6%
Urinary tract infection viral
6%
Postoperative wound complication
6%
Amylase increased
6%
Hypocalcaemia
6%
Wound haematoma
6%
Asthenia
6%
Blood creatinine increased
6%
Graft complication
6%
Blood lactate dehydrogenase increased
6%
Urinary retention
6%
Paraesthesia
6%
Dysphagia
6%
Sleep apnoea syndrome
6%
Seroma
6%
Penile pain
6%
Proteinuria
6%
Rhinitis
6%
Latent tuberculosis
6%
Lung infection
6%
Mucocutaneous candidiasis
6%
Gamma-glutamyltransferase increased
6%
Vitamin D decreased
6%
Folate deficiency
6%
Weight increased
6%
Fluid overload
6%
Pityriasis
6%
Vitamin D deficiency
6%
Hypercreatinaemia
6%
Pancytopenia
6%
Gingival pain
6%
Pyrexia
6%
Kidney transplant rejection
6%
Hepatomegaly
6%
Epstein-Barr virus infection
6%
Lymphocele
6%
Incision site complication
6%
Deep vein thrombosis
6%
Hyperlipidaemia
6%
Back pain
6%
Muscle spasms
6%
Muscle twitching
6%
Hypoaesthesia
6%
Leukocyturia
6%
Restlessness
6%
Angina pectoris
6%
Basosquamous carcinoma
6%
Normocytic anaemia
6%
Tricuspid valve incompetence
6%
Peripheral swelling
6%
Conjunctivitis
6%
Gastroenteritis norovirus
6%
Gastroenteritis viral
6%
Bladder pain
6%
Perinephric oedema
6%
Urinary tract obstruction
6%
Benign prostatic hyperplasia
6%
Hydrocele
6%
Gastric polyps
6%
Tachycardia
6%
Tinea versicolour
6%
Blood creatine phosphokinase increased
6%
Encephalitis
6%
Polycythaemia
6%
Arrhythmia
6%
Hyperparathyroidism secondary
6%
Abdominal discomfort
6%
Abdominal pain lower
6%
Anal fissure
6%
Dyspepsia
6%
Gastritis haemorrhagic
6%
Gingival recession
6%
Odynophagia
6%
Oesophagitis
6%
Malaise
6%
Pyuria
6%
Tooth infection
6%
Hyponatraemia
6%
Chronic kidney disease
6%
Renal tubular acidosis
6%
Renal tubular injury
6%
Sterile pyuria
6%
Night sweats
6%
Ileus
6%
Infection
6%
Influenza
6%
Incarcerated incisional hernia
6%
Arteriovenous fistula site complication
6%
Post procedural swelling
6%
C-reactive protein increased
6%
Drug level decreased
6%
Hyperphosphataemia
6%
Groin pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tac + MMF (Part 2)
CFZ533 + TAC + MMF (Part 1)
CFZ533 + MMF (Part 2)
Total
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
2013
Completed Phase 2
~660
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,293 Total Patients Enrolled
7 Trials studying Lupus Nephritis
1,134 Patients Enrolled for Lupus Nephritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom does the enrollment criteria for this medical experiment extend?
"This clinical trial requires that participants have lupus nephritis and are between 18 to 75 years old. The study is seeking a total of 57 enrollees."
Answered by AI
Does the eligibility criteria for this clinical trial allow those beneath 60 years of age to participate?
"The age range for eligibility into this clinical trial is 18 to 75, as indicated in the inclusion criteria."
Answered by AI
Are there any openings presently available to enrollees for this research?
"According to the listing on clinicaltrials.gov, this particular research initiative is not presently recruiting patients. It was originally posted in September 2018 and last edited November 2022. Although no longer seeking enrollees, there are 40 alternate studies enrolling participants at this time."
Answered by AI
What aims is this medical trial aiming to accomplish?
"The Novartis Pharmaceuticals study sponsor has reported that the primary objective of this trial, measured over 25 weeks, is to assess safety through adverse events. Additionally, secondary outcomes such as Urine protein creatinine ratio (UPCR) and hematuria and cellular casts will be noted in order to evaluate renal effect. Plasma pharmacokinetics (PK) of CFZ533 which includes AUClast: area under plasma concentration-time curve calculated to the last quantifiable concentration point and complete renal remission according to ACR recommendation are also being monitored."
Answered by AI
Has CFZ533 been granted permission to be distributed by the Food and Drug Administration?
"Our experts at Power rated the safety of CFZ533 as a 2, due to evidence from Phase 2 trials that suggests this drug has some secure properties but no data attesting to its efficacy."
Answered by AI
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