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Monoclonal Antibody

CFZ533 for Liver Transplant Rejection (CONTRAIL I Trial)

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 to month 12 and month 24
Awards & highlights

CONTRAIL I Trial Summary

This trial is testing a new drug to see if it's safe and effective in liver transplant patients, as well as how it is metabolized and affects the body.

CONTRAIL I Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 12 and month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 12 and month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with composite event (BPAR, Graft Loss or Death) over 12 months
Secondary outcome measures
Proportion of patients with AEs and SAEs
Proportion of patients with premature discontinuation from study and premature discontinuation of study drug
To mean eGFR up to Month 24 post-transplantation

Side effects data

From 2017 Phase 1 & 2 trial • 59 Patients • NCT02217410
71%
Hypophosphataemia
57%
Nausea
43%
Dyspnoea
43%
Incision site pain
43%
Vomiting
43%
Secretion discharge
43%
BK virus infection
43%
Hyperglycaemia
29%
Diarrhoea
29%
Vitamin D deficiency
29%
Dyspepsia
29%
Hypomagnesaemia
29%
Tachycardia
29%
Hyperparathyroidism secondary
29%
Eye movement disorder
29%
Oedema peripheral
29%
Tremor
14%
Dizziness
14%
Dizziness postural
14%
Incision site erythema
14%
Acne
14%
Hyperlipidaemia
14%
Fatigue
14%
Micturition urgency
14%
Constipation
14%
Radius fracture
14%
Alopecia
14%
Complications of transplanted kidney
14%
Headache
14%
Abdominal pain
14%
Mouth ulceration
14%
Weight decreased
14%
Phonophobia
14%
Hyperkalaemia
14%
Pulmonary embolism
14%
Deep vein thrombosis
14%
Urinary tract infection
14%
Hypertension
14%
Vision blurred
14%
Pancreatitis
14%
Nocturia
14%
Photophobia
14%
Anaemia
14%
Leukocytosis
14%
Leukopenia
14%
Abdominal distension
14%
Aphthous ulcer
14%
Paraesthesia oral
14%
Generalised oedema
14%
Influenza like illness
14%
Pain
14%
Paraesthesia
14%
Hypokalaemia
14%
Anxiety
14%
Insomnia
14%
Dysuria
14%
Productive cough
14%
Wheezing
14%
Orthostatic hypotension
14%
Cardiac murmur
14%
Nasopharyngitis
14%
White blood cell count decreased
14%
Complications of transplant surgery
14%
Blood phosphorus decreased
14%
Electrocardiogram ST segment abnormal
14%
Groin pain
14%
Muscle spasms
100%
80%
60%
40%
20%
0%
Study treatment Arm
CFZ533 + TAC + MMF (Part 1)
CFZ533 + MMF (Part 2)
Tac + MMF (Part 2)
Total

CONTRAIL I Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 3Experimental Treatment1 Intervention
CFZ533 300mg dose + MMF + Corticosteroids
Group II: Arm 2Experimental Treatment1 Intervention
CFZ533 600mg dose + MMF + Corticosteroids
Group III: Arm 1Active Control1 Intervention
Control/Standard of Care: TAC + MMF + Corticosteroids
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
2,851 Previous Clinical Trials
4,197,460 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I take part in this experiment if I meet the requirements?

"This clinical trial is admitting 132 patients, between the ages of 18 and 70 who have rejection; transplant, liver. It is important that participants also meet the following criteria: Screening period up to liver transplantation: -Written informed consent obtained before any assessment., Recipients of a primary liver transplant from a deceased donor., Up to date vaccination as per local immunization schedules., MELD score ≤30., Allograft is functioning at an acceptable level by the time of randomization as defined by AST, ALT, Alkaline Phosphatase levels ≤ 5 times ULN and Total bilirubin ≤ 2"

Answered by AI

What are the conditions that CFZ533 can help treat?

"CFZ533 is most commonly used as an atopic dermatitis medication, but it can also be effective in treating transplant rejection (liver and kidney), as well as psoriasis."

Answered by AI

Are there any serious dangers associated with taking CFZ533?

"CFZ533 has received a score of 2 in regards to safety. While there is Phase 2 trial data supporting its safety, there are no efficacy studies as of yet."

Answered by AI

Could you tell me if CFZ533 has been explored in other research?

"There are a total of 153 clinical trials researching CFZ533, with 18 of them being in Phase 3. The largest concentration of these studies is located in Pennsylvania near Philadelphia; however, research is being conducted at 875 different locations worldwide."

Answered by AI

How many people are being included in this experiment?

"This particular clinical trial is no longer recruiting patients. The initial posting was on October 7th, 2019 and the most recent update was on October 14th, 2020. There are 6 other trials currently admitting participants who have rejection; transplant, liver and 153 studies for CFZ533 that are also actively seeking patients."

Answered by AI

Does this trial encompass patients who are over 20 years old?

"The age limit for enrolment in this study is 70 years old. All patients that meet this criteria and are above the age of 18 may participate."

Answered by AI

Are there any available appointments for this study?

"This study is not taking any more participants at the moment. According to the information on clinicaltrials.gov, this trial was first posted on October 7th 2019 and was last updated on October 14th 2020. If you are looking for other studies, there are currently 6 trials related to rejection; transplant, liver and 153 trials for CFZ533 that are admitting patients right now."

Answered by AI

In how many areas is this research being conducted?

"There are 12 sites currently enrolling patients for this study, which are located in cities such as Boston, Dallas and San Francisco. If you decide to participate in the trial, try to select a location close to minimize travel demands."

Answered by AI
~24 spots leftby Mar 2025