Delayed Graft FunctionPhase 2NCT01286727
Study to Improve Renal Function After Kidney Transplantation
A Phase 2 study testing BB3 in people with Delayed Graft Function, run by Angion Biomedica Corp at 6 sites in United States.
Trial summary
The objective of the study is to evaluate the safety and activity of a investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- BB3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2010to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age
- Had renal transplantation due to end stage disease requiring chronic dialysis
- Study drug can be administered within 36 hours after transplantation
- Received kidney from healthy donor or donor with history of diabetes mellitus or hypertension
- Donor terminal serum creatinine ≤ 2.2 mg/dL.
- 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 at 24 hours after transplantation to pre-transplantation is < 30%.
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- Reason for low urine output is unlikely due to structural changes. If clinically indicated, an ultrasound will be performed
- Dry weight to< 120kg and BMI <35
- Women of child bearing potential have a negative serum 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 28-day study period.
- In the opinion of the investigator, the subject is capable of understanding and complying with the protocol.
- Subjects must have signed the informed consent document prior to performance of any study related procedure including screening procedure.
Who cannot join
- Subject with normal urine output and not requiring dialysis prior to renal transplantation (i.e., had pre-emptive renal transplantation).
- Signs and symptoms of volume depletion.
- Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
- Recipient of pediatric en-bloc kidney transplantation.
- Recipient of kidney with cold ischemia time > 40 hours
- Has measurable donor-specific antibody or positive cross-match requiring deviation from standard immunosuppressive therapy.
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- 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 enrollment 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 are breast feeding.
- History of positive HIV test.
- History of rheumatoid arthritis.
- Subjects who require the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin and/or 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Division of Transplant Surgery, University of Maryland School of Medicine, University of Maryland Medical Center
Baltimore, Maryland, 21201
State University of New York at Buffalo
Buffalo, New York, 14215
The Methodist Hospital
Houston, Texas, 77030
California Institute of Renal Research
San Diego, California, 92123
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Multicenter Pilot Study of BB3 to Improve Renal Function in Patients With Signs and Symptoms of Significant Renal Injury After Kidney Transplantation and at Risk for Dialysis
The objective of the study is to evaluate the safety and activity of a investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis.
Read the detailed description
Delayed graft function (DGF) is generally defined as the need for dialysis during the first 7 days after transplantation although the definition can also include failure to improve preexisting renal function. DGF is an important problem in renal allograft transplantation that affects approximately 25% of transplanted cadaveric kidneys. It has generally been observed that delayed graft function has been associated with reduced graft survival. In addition to an association of DGF with graft loss, DGF imposes an economic burden due to prolonged hospitalization and dialysis. The strongest association with occurrence of DGF is ischemia around the time of transplantation. Aside from approaches to minimize ischemia time and use of antibody induction, there are no good specific therapeutic options to prevent or treat delayed graft function. This study is designed to evaluate the safety and activity of an investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis.
- Conditions
- Delayed Graft Function
- Being tested
- BB3
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB3Drug
intravenous drug
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Placebo |
| BB3 | Active comparator | Not described Receives: Drug: BB3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine production
mean time (days) until production of ≥ 50 cc/H of urine over a 12 hour period
Measured: 28 days
Secondary outcomes (10)
Change from baseline urine production
Change from baseline urine production (cc/H) at each of the following time points: Day 3, Day 7, Day 14, and Day 28
Measured: 28 days
creatinine clearance
Mean measured 24-hour creatinine clearance at Days 3, 7, 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 7 days after transplantation)
Measured: 7 days
Number of dialysis sessions
Number of dialysis sessions through Day 7, 14, and 28
Measured: 28 days
Daily urine output
Mean total daily urine output through Day 14
Measured: 14 days
Mean serum creatinine
Mean serum creatinine at Days 4, 7, 10, 14, and 28
Measured: 28 days
Number of acute rejection episodes
Number of acute rejection episodes
Measured: 28 days
Length of hospitalization following transplantation
Length of hospitalization following transplantation
Measured: 28 days
Biomarkers
Comparison of biomarkers
Measured: 28 days
adverse events, clinical laboratory evaluations, vital signs, ECG results
Safety assessments include adverse events, clinical laboratory evaluations, vital signs, ECG results.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startFeb 2010
- Primary completionJan 2015
- Study completionFeb 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weizhong Cai, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286727
- Sponsor's protocol ID
- 001-09
- Other IDs
- 2R44DK066654
- Status last verified
- Oct 2014
- First submitted
- 27 Jan 2011
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot Study of BB3 to Improve Renal Function in Patients With Signs and Symptoms of Significant Renal Injury After Kidney Transplantation and at Risk for Dialysis
- ClinicalTrials.gov ID
- NCT01286727
- Acronym / sponsor ID
- 001-09
- Conditions
- Delayed Graft Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2016 (estimated)
- First posted
- 31 Jan 2011 (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 objective of the study is to evaluate the safety and activity of a investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis.
Detailed description
Delayed graft function (DGF) is generally defined as the need for dialysis during the first 7 days after transplantation although the definition can also include failure to improve preexisting renal function. DGF is an important problem in renal allograft transplantation that affects approximately 25% of transplanted cadaveric kidneys. It has generally been observed that delayed graft function has been associated with reduced graft survival. In addition to an association of DGF with graft loss, DGF imposes an economic burden due to prolonged hospitalization and dialysis. The strongest association with occurrence of DGF is ischemia around the time of transplantation. Aside from approaches to minimize ischemia time and use of antibody induction, there are no good specific therapeutic options to prevent or treat delayed graft function. This study is designed to evaluate the safety and activity of an investigational drug in improving renal function in patients who have undergone renal transplantation and have signs and symptoms of significant renal injury and are at risk for dialysis.
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 | –Placebo |
| BB3 | Active comparator | Drug: BB3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males and females ≥ 18 years of age
- Had renal transplantation due to end stage disease requiring chronic dialysis
- Study drug can be administered within 36 hours after transplantation
- Received kidney from healthy donor or donor with history of diabetes mellitus or hypertension
- Donor terminal serum creatinine ≤ 2.2 mg/dL.
Key exclusion criteria (15 listed)
- Subject with normal urine output and not requiring dialysis prior to renal transplantation (i.e., had pre-emptive renal transplantation).
- Signs and symptoms of volume depletion.
- Recipient of multiple organ transplantation or scheduled for multiple organ transplantation.
- Recipient of pediatric en-bloc kidney transplantation.
- Recipient of kidney with cold ischemia time > 40 hours
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 |
|---|---|---|
| BB3intravenous drug | Drug | BB3 |
Primary outcome
Urine production
Time frame: 28 days
mean time (days) until production of ≥ 50 cc/H of urine over a 12 hour period
10 secondary outcomes
Change from baseline 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
Daily urine output
Time frame: 14 days
Mean serum creatinine
Time frame: 28 days
Number of acute rejection episodes
Time frame: 28 days
Length of hospitalization following transplantation
Time frame: 28 days
Biomarkers
Time frame: 28 days
adverse events, clinical laboratory evaluations, vital signs, ECG results
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
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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.
Weizhong Cai, PhD study director
Sponsor GmbH
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BB3 in people with Delayed Graft Function, run by Angion Biomedica Corp at 6 sites in United States.
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 12 inclusion and 15 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 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Urine production (time frame: 28 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 5 May 2015.