Delayed Graft FunctionPhase 2NCT01561599
Study on Delayed Graft Function Using Paired Kidneys
A Phase 2 study testing BB3 and Normal Saline in people with Delayed Graft Function, run by Angion Biomedica Corp at 3 sites in 3 countries.
Trial summary
The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from cardiac death donors who are risk for developing delayed graft function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- BB3 and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2011to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must sign the informed consent document prior to performance of any study related procedure including the Screening procedure.
- Males and females ≥ 18 years of age.
- Had renal transplantation due to end stage disease requiring chronic dialysis.
- Study drug can be administered within 6 to 36 hours after transplantation.
- Received kidney from donor after cardiac death.
- DCD kidney fulfills the clinical site's criteria for transplantation.
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- Creatinine clearance from the transplanted kidney over a 2-hour collection period is <10 mL/min, OR no urine output OR average urine output of < 50 cc/H over 8 or more consecutive hours,, OR normal urine output following transplantation that diminished to average of < 50 cc/H over 8 or more consecutive hours, OR Creatinine reduction ratio 24 hours after transplantation to pre-transplantation is < 30%.
- Dry weight ≤ 100 kg.
- Women of child bearing potential have a negative pregnancy test prior to transplantation.
- Women of child bearing potential (including perimenopausal women who have had a menstrual period within 1 year) must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the 28-day study period. Men must agree to use condoms during the study period; a condom with spermicide is considered a single barrier.
- In the opinion of the Investigator, the subject is capable of understanding and complying with the protocol.
Who cannot join
- Mean arterial pressure <40 mmHg or cardiac index <1.8 L/min/m2.
- Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
- Recipient of kidney from a pediatric donor age 10 years or less.
- Recipient age > 75 years.
- Patients with ASA 4 or 5
- Patients with chronic obstructive pulmonary disease (COPD) GOLD IV
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- Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy.
- Currently participating in or has participated in an investigational drug or medical device study within 30 days or five half-lives, whichever is longer, prior to enrolment into this study.
- Concurrent sepsis or active bacterial infection.
- Have an active malignancy or history of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
- Women of child bearing potential who is breast feeding.
- History of positive HIV test.
- History of rheumatoid arthritis.
- History of proliferative retinopathy or laser surgery for retinopathy.
- Subjects who have a penicillin allergy.
- Subjects who require the cytochrome P450 1A2 (CYP1A2) inhibitors, or are receiving ciprofloxacin and fluvoxamine (Luvox®).
- Subject is unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
- Subject is not deemed medically stable for the study in the opinion of the Investigator or the subject's primary nephrologist.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Netherlands1 site
Maastricht University Medical Center
Minderbroedersberg, Maastricht, 6211 LK
United Kingdom1 site
The Newcastle Upon Tyne Hospital
Newcastle, Metropolitan County of Tyne and Wear, NE7 7DN
About this study
Official title: Pilot Study of BB3 to Improve Renal Function in Patients With Signs and Symptoms of Significant Renal Injury After Kidney Transplantation From Donors After Cardiac Death
The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from cardiac death donors who are risk for developing delayed graft function.
Read the detailed description
Renal transplantation is the most effective and cost-efficient form of renal replacement therapy for a burgeoning population that presents with end-stage renal disease. Although organ donation has become a national priority, the gap between the number of patients awaiting a kidney versus the number of available kidneys continues to widen exponentially. In many countries within the European Union, utilization of "donation after cardiac death" (DCD) kidneys is steadily increasing, expanding the donor pool by > 50%. Given the high incidence of cardiac deaths in the US, aggressive pursuit of the DCD kidney pool could potentially reduce waitlist periods to months, if not days. Risk for delayed graft function (DGF) with the attendant risks for increased recipient morbidity, chronic allograft nephropathy and increased medical costs has however tempered DCD kidney utilization in this country. Development of strategies that limit normothermic reperfusion injury, promote renal repair, reduce the incidence and/or duration of DGF and improve long-term outcome can greatly enhance acceptance and recruitment of DCD kidneys. The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from DCD donors who are risk for developing DGF. This trial is unique in that it compares drug versus placebo outcome in kidney recipients from the same donor with direct evaluation of function (creatinine clearance) in the graft.
- Conditions
- Delayed Graft Function
- Being tested
- BB3, Normal Saline
- Keywords
- hepatocyte growth factor mimetic, hepatocyte growth factor(HGF), Delayed Graft Function (DGF), Kidney transplantation
- Medical subject headings
- Delayed Graft Function, Deafness, Autosomal Recessive 39
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB3Drug
Daily intravenous administration of 2mg/kg for 4 days
Normal SalineDrug
Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Placebo Receives: Drug: Normal Saline |
| BB3 | Active comparator | Small molecule mimetic of hepatocyte growth factor/scatter factor Receives: Drug: BB3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
creatinine clearance
The primary analysis to assess the activity of BB3 compared to placebo will be the mean difference in creatinine clearance over time using selective 24-hour urine collections from the transplanted kidney from the first infusion of study drug through day 7 post-transplant.
Measured: 7 days
Secondary outcomes (9)
Urine production
Median time (days) until production of ≥1 litre urine over a 24-hour period, i.e. median number of days following the first infusion of study drug until the first day (08:00 - 08:00) that urine production was ≥1 litre over a 24-hour period.
Measured: 28 days
Creatinine clearance
Calculated creatinine clearance at days 14 and 28
Measured: 28 days
Incidence of delayed graft function
Incidence of delayed graft function (required dialysis due to inadequate renal function during the first 7 days after transplantation).
Measured: 7 days
Number of dialysis sessions
Number of dialysis sessions through day 7, 14, and 28
Measured: 28 days
Mean total daily urine output
Mean total daily urine output through day 14
Measured: 14 days
Daily serum creatinine
Daily serum creatinine at days 1 to 7
Measured: 7 days
Mean serum creatinine
Mean serum creatinine at days 4, 7, 10, 14, and 28
Measured: 28 days
Length of hospitalization following transplantation
Length of hospitalization following transplantation
Measured: 28 days
Follow-up on graft survival and function
Results of the 6- and 12-month follow-up on graft survival and function will be summarized as an addendum to the final clinical study report
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionFeb 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561599
- Sponsor's protocol ID
- 004-09
- Other IDs
- 2010-019243-19, 2R44DK078455-02
- Status last verified
- Feb 2016
- First submitted
- 21 Mar 2012
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of BB3 to Improve Renal Function in Patients With Signs and Symptoms of Significant Renal Injury After Kidney Transplantation From Donors After Cardiac Death
- ClinicalTrials.gov ID
- NCT01561599
- Acronym / sponsor ID
- 004-09
- Conditions
- Delayed Graft Function
- Keywords
- hepatocyte growth factor mimetic, hepatocyte growth factor(HGF), Delayed Graft Function (DGF), Kidney transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Aug 2011
- Primary completion
- Feb 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from cardiac death donors who are risk for developing delayed graft function.
Detailed description
Renal transplantation is the most effective and cost-efficient form of renal replacement therapy for a burgeoning population that presents with end-stage renal disease. Although organ donation has become a national priority, the gap between the number of patients awaiting a kidney versus the number of available kidneys continues to widen exponentially. In many countries within the European Union, utilization of "donation after cardiac death" (DCD) kidneys is steadily increasing, expanding the donor pool by > 50%. Given the high incidence of cardiac deaths in the US, aggressive pursuit of the DCD kidney pool could potentially reduce waitlist periods to months, if not days. Risk for delayed graft function (DGF) with the attendant risks for increased recipient morbidity, chronic allograft nephropathy and increased medical costs has however tempered DCD kidney utilization in this country. Development of strategies that limit normothermic reperfusion injury, promote renal repair, reduce the incidence and/or duration of DGF and improve long-term outcome can greatly enhance acceptance and recruitment of DCD kidneys. The study is designed to evaluate the safety and efficacy of an intravenously administered drug in recipients of kidneys from DCD donors who are risk for developing DGF. This trial is unique in that it compares drug versus placebo outcome in kidney recipients from the same donor with direct evaluation of function (creatinine clearance) in the graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Drug: Normal SalinePlacebo |
| BB3 | Active comparator | Drug: BB3Small molecule mimetic of hepatocyte growth factor/scatter factor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must sign the informed consent document prior to performance of any study related procedure including the Screening procedure.
- Males and females ≥ 18 years of age.
- Had renal transplantation due to end stage disease requiring chronic dialysis.
- Study drug can be administered within 6 to 36 hours after transplantation.
- Received kidney from donor after cardiac death.
Key exclusion criteria (18 listed)
- Mean arterial pressure <40 mmHg or cardiac index <1.8 L/min/m2.
- Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
- Recipient of kidney from a pediatric donor age 10 years or less.
- Recipient age > 75 years.
- Patients with ASA 4 or 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB3Daily intravenous administration of 2mg/kg for 4 days | Drug | BB3 |
| Normal SalineDaily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight. | Drug | Normal saline |
Primary outcome
creatinine clearance
Time frame: 7 days
The primary analysis to assess the activity of BB3 compared to placebo will be the mean difference in creatinine clearance over time using selective 24-hour urine collections from the transplanted kidney from the first infusion of study drug through day 7 post-transplant.
9 secondary outcomes
Urine production
Time frame: 28 days
Creatinine clearance
Time frame: 28 days
Incidence of delayed graft function
Time frame: 7 days
Number of dialysis sessions
Time frame: 28 days
Mean total daily urine output
Time frame: 14 days
Daily serum creatinine
Time frame: 7 days
Mean serum creatinine
Time frame: 28 days
Length of hospitalization following transplantation
Time frame: 28 days
Follow-up on graft survival and function
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BB3 and Normal Saline in people with Delayed Graft Function, run by Angion Biomedica Corp at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
creatinine clearance (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.