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Costimulation Blockade

VIB4920 for Allograft

Phase 2
Waitlist Available
Research Sponsored by Viela Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recipients of a first renal transplant from standard criteria deceased, living unrelated or HLA non-identical living related donor.
No donor specific antibodies (DSA),
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, 24, 48
Awards & highlights

Study Summary

This trial will test a new immunosuppressant drug to see if it is effective, safe, and tolerated in patients who have received a kidney transplant from a deceased, living unrelated, or HLA non-identical living related donor.

Eligible Conditions
  • Allograft
  • Transplant Rejection
  • Kidney Transplant
  • Kidney Transplant Rejection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have received your first kidney transplant from a non-identical donor.
Select...
Your body does not have specific antibodies against the donor's organs or tissues.
Select...
Your blood has to match with the donor's blood in order to participate.
Select...
You have received all the necessary vaccinations according to your country's immunization schedule.
Select...
You agree to use birth control methods as outlined in the study protocol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, 24, 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, 24, 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Treated Biopsy-proven Acute Rejection (tBPAR) of Grade 1A or Higher, Graft Loss or Death at Week 24
Secondary outcome measures
Percentage of Participants With Antibody-Mediated Rejection
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)
Percentage of Participants With De Novo Donor-specific Antibodies (dnDSA)
+4 more

Side effects data

From 2023 Phase 2 trial • 25 Patients • NCT04046549
22%
COVID-19
17%
Anaemia
17%
Leukopenia
17%
BK virus infection
17%
Hypophosphataemia
13%
Arthralgia
13%
Headache
9%
Metabolic acidosis
9%
Insomnia
9%
Pain in extremity
9%
Neutropenia
9%
Hypokalaemia
9%
Post procedural urine leak
9%
Urinary tract infection
9%
Procedural pain
4%
Arteriovenous fistula site complication
4%
Bacteraemia
4%
Blood creatinine increased
4%
Subcapsular renal haematoma
4%
Urosepsis
4%
Diabetic foot infection
4%
Cytomegalovirus test positive
4%
Clostridium difficile infection
4%
Ileus
4%
Hypervolaemia
4%
Depression suicidal
4%
Cholecystitis acute
4%
Kidney transplant rejection
4%
Ureteric stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept+VIB4920

Trial Design

1Treatment groups
Experimental Treatment
Group I: Belatacept+VIB4920Experimental Treatment4 Interventions
Participants will be admitted to the transplant center for the administration of VIB4920 and belatacept (with Thymoglobulin and corticosteroids) and will be discharged on Day 3/4 at the discretion of the investigator. Participants will return to the study center to receive study drugs (VIB4920 and /or belatacept) weekly for 2 visits, then every 2 weeks for 5 visits, and then monthly for 9 visits for safety monitoring.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
2015
Completed Phase 4
~2280
Belatacept
2013
Completed Phase 4
~2210
VIB4920
2019
Completed Phase 2
~350
Thymoglobulin
2005
Completed Phase 4
~1500

Find a Location

Who is running the clinical trial?

Viela BioLead Sponsor
12 Previous Clinical Trials
1,104 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
946 Total Patients Enrolled
Gabor Illei, MDStudy DirectorViela Bio
1 Previous Clinical Trials
834 Total Patients Enrolled

Frequently Asked Questions

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

What are the various locations where this experiment can be conducted?

"This research is accepting participants at four seperate locations, based in Dallas, Los Angeles and Durham. To reduce the burden of travel for all involved, it's recommended that you select the centre nearest to your residence when applying."

Answered by AI

To what degree is VIB4920 hazardous to human health?

"Based on the data our team has reviewed, VIB4920 is estimated to have a safety level of 2. This Phase 2 trial provides evidence that it's safe but not necessarily effective in treating conditions."

Answered by AI

Who is eligible to be involved in this medical research experiment?

"This clinical trial is recruiting 20 individuals who have experienced organ transplant rejection, ranging from 18 to 70 years old. The primary recruitment criteria are as follows: recipients of a first renal transplant from standard dead or living donors; negative cross-match testing results; and agreement by both sexes to abide by contraceptive protocols outlined in the study."

Answered by AI

How many participants are being admitted to this clinical examination?

"At the moment, this trial is not accepting patient applications. Initially posted on October 30th 2019 and last modified on August 11th 2022, currently individuals seeking clinical trials have 123 other studies to choose from if they are looking for rejection or transplant treatments; there are also 12 ongoing investigations that require VIB4920 participants."

Answered by AI

Is the recruitment phase of this clinical trial still ongoing?

"The clinical trial referenced is no longer actively recruiting, as confirmed from the information found on clinicaltrials.gov. The research was first posted 10/30/2019 and last amended 8/11/2022 - although other trials are still looking for patients to join their studies."

Answered by AI

Has research been conducted on the efficacy of VIB4920 in past studies?

"VIB4920 was initially studied at Duke University Health System in 2018, with 33 trials completed since. Currently, 12 medical studies are accepting participants and most of them are located around Dallas, Texas."

Answered by AI

Has there ever been a comparable experiment before this one?

"Currently, 12 clinical trials for VIB4920 are ongoing in various metropolitan areas throughout 8 countries. Rho Federal Systems Division Inc first initiated a Phase 1 trial with 6 patients back in 2018; since then, an additional 33 studies have been conducted."

Answered by AI

Is the age range for this experiment encompassing those aged 80 or above?

"The lower limit for participation in this trial is 18 years old, while the upper bound is 70."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
2019. "A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04046549.
~5 spots leftby Apr 2025
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