A Phase 2 interventional study of OPN-305 and Placebo in Delayed Graft Function, sponsored by Opsona Therapeutics Ltd.. Completed at 50 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-16.
Sponsored by Opsona Therapeutics Ltd. · Phase 2, Interventional, and Prevention
When a patient receives a kidney transplant particularly if the kidney is from an older donor or one who has had the kidney removed after their heart has stopped, there is a risk that the newly transplanted kidney may not function immediately. If the delay in function means that dialysis is needed in the first 7 days after the transplantation then this is known as delayed graft function or dDGF. Also delayed graft function that does not require dialysis but is present because the serum creatinine does not fall sufficiently is known as functional delayed graft function or fDGF. This problem is often due to an excessive inflammatory reaction to not having had a blood supply between the time of donation and transplant.
OPN-305 is a monoclonal antibody that blocks Toll-like Receptor 2 which is thought to be partly responsible for increasing the risk of this inflammation. It is hoped that the effects of the inflammation will be reduced and therefore prevent dDGF and fDGF from occurring.
The purpose of the study is to explore how effective OPN-305 is in preventing dDGF and fDGF as well as improving other measures of kidney function and the overall safety of the antibody. In the first part of the study, each patient received an Infusion of one of three possible doses of OPN-305 or a placebo and in the second part the most suitable dose of OPN-305 and a placebo would be used. The purpose of this second part of the study is to find out if a dose of OPN-305 which has already been tested in an earlier part of this study can prevent kidney graft dysfunction. For the purposes of this study, kidney function will be assessed using the composite of delayed graft function (dDGF) because dialysis is necessary in the first 7 days and functional delayed graft function that does not require dialysis but is present because the serum creatinine, a key measure of renal function, does not fall sufficiently (fDGF) in the first 7 days post-transplant.
Protocol OPN305-103 follows out to 12 months post-transplant the clinical status and graft function of patients who have completed the 6-month post-transplant period under Part A or Part B of OPN305-102.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 252 is above the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →Opsona Therapeutics Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
INCLUSION CRITERIA FOR TRANSPLANT RECIPIENTS
First or second renal transplant recipient - for second renal transplantations;
Dialysis-dependent at the time of transplantation as documented by:
INCLUSION CRITERIA FOR DONOR KIDNEY:
An ECD donor defined as:
o Extended Criteria Donor defined as:
Exclusion Criteria
EXCLUSION CRITERIA FOR TRANSPLANT RECIPIENTS:
EXCLUSION CRITERIA FOR ALL DONOR KIDNEYS
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: OPN-305
Drug: Placebo
Intravenous infusion for 1 hour at start of transplant procedure
Intravenous infusion for 1 hour at start of transplant procedure
Measure of Early Graft Function EGF
Initiation of dialysis in the first 7 days following renal transplantation and failure of serum creatinine to decrease by at least 10% daily on 3 successive days during the first week post transplantation
Time frame: First 7 days following renal transplantation
Creatinine at 7 and 14 days and at 1, 3 and 6 months
Measure of creatinine at 7 and 14 days and at 1, 3 and 6 months
Time frame: 7 and 14 days and at 1, 3 and 6 months
Cystatin C at 7 and 14 days and at 1, 3 and 6 months
Measure of Cystatin C at 7 and 14 days and at 1, 3 and 6 months
Time frame: 7 and 14 days and at 1, 3 and 6 months
Symmetrical dimethylarginine at 7 and 14 days and at 1, 3 and 6 months
Measure of symmetrical dimethylarginine at 7 and 14 days and at 1, 3 and 6 months
Time frame: 7 and 14 days and at 1, 3 and 6 months
Incidence of slow graft function
Slow graft function to be assessed over first 5 days post-transplant
Time frame: 5 days post-transplant
Serum creatinine over time
Measure of Serum creatinine over time
Time frame: over the duration of follow-up
Composite endpoint
Components of the composite endpoint are: 1. Incidence of biopsy-proven kidney allograft rejection (biopsies will be done on a for-cause basis only) 2. Graft loss 3. Reports of patient death(s) 4. Patients lost to follow-up
Time frame: 6 months
Time to biopsy-proven kidney allograft rejection
Time to biopsy-proven kidney allograft rejection
Time frame: 6 months
Time to first dialysis or functional delayed graft function and delayed graft function duration
Duration of DGF is defined as either: Time from transplantation to time of completion of final dialysis for DGF Time from transplantation to time when creatinine starts to fall by at least 10% without dialysis
Time frame: 30 days
Blood and urine biomarkers for acute kidney injury (AKI)
Serum NGAL, urinary NGAL, α-GST, π-GST, KIM-1 and IL-18
Time frame: days 2, 7, 14, 28, 90 and 180
Duration of initial hospitalization
Duration of initial hospitalization
Time frame: 6 months
Duration of subsequent readmissions
Duration of subsequent readmissions
Time frame: 6 months
Reason for subsequent readmissions
Reason for subsequent readmissions
Time frame: 6 months
Number of Adverse events (AEs)
Number of Adverse events (AEs)
Time frame: 6 months
Nature of Adverse events (AEs)
Nature of Adverse events (AEs)
Time frame: 6 months
Incidence of infections
Incidence of infections by category and organism
Time frame: 6 months
Rate of primary non-function (permanent lack of function of the allograft)
Time frame: 6 months
Number of dialysis sessions between 0 and 30 days post-transplantation
Number of dialysis sessions between 0 and 30 days post-transplantation
Time frame: 30 days
The record gives a start of Oct 2012, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tomaralimab
Opsona Therapeutics Ltd.