Acute Kidney InjuryPhase 2NCT01336959
Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery
A Phase 2 study testing BCT197 Part A and BCT197 Part B in people with Acute Kidney Injury, run by Mereo BioPharma at 13 sites in 3 countries.
Trial summary
This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- BCT197 Part A and BCT197 Part B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Sep 2011to Nov 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective cardiac surgery with CPB. Allowable procedures are CABG alone, aortic valve replacement or repair alone, mitral valve replacement or repair alone, CABG with aortic valve replacement or repair, and CABG with mitral valve replacement or repair. Patients with repeat surgery for any of the procedures can be included.
- Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) 18 kg/m2
- Have an eGFR ≥ 30 and ≤ 60 mL/min/1.73 m2 to participate in Part A, or an eGFR > 60 mL/min/1.73 m2 to participate in Part B. Upon completion of Part A, patients with eGFR ≥ 30 mL/min/1.73 m2 may participate in Part B, with dose administered as per the dosing table
Who cannot join
- left ventricular ejection fraction, in the last 6 months, ≥30%
- Active systemic infection or uncontrolled diabetes mellitus with a glucose ≥250 mg% at the screening assessment
- Pregnant or nursing (lactating) women,
- Female subjects must either:
- have been surgically sterilized or hysterectomized at least 6 months prior to study participation, or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to study participation. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow- up hormone level assessment is she considered not of child bearing potential, Surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF, OR be postmenopausal. Female subjects are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). Female subjects 60 years of age or younger must confirm menopause by the demonstration of a plasma FSH level in the postmenopausal range according to the lab normal range. Documentation of a prior plasma FSH level is acceptable
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of drug abuse as indicated by the laboratory assays conducted during screening or baseline
- New cancer diagnosis with planned chemotherapy and/or radiation therapy, or cancer requiring ongoing chemotherapy and/or radiation therapy at the time of screening
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United States6 sites
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Falls Church, Virginia, 22042
Novartis Investigative Site
Lincoln, Nebraska, 68506
Novartis Investigative Site
Orange, California, 92686
Novartis Investigative Site
Saginaw, Michigan, 48601
Novartis Investigative Site
Wynnewood, Pennsylvania, 19096
Israel6 sites
Novartis Investigative Site
Beersheba, 84101
Novartis Investigative Site
Herzliya
Novartis Investigative Site
Jerusalem, 91031
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Rehovot, 76100
Novartis Investigative Site
Tel Aviv, 69710
About this study
Official title: A Two-part, Randomized, Double-blind, Placebo-controlled, Single Dose Study of BCT197 for the Prevention of Acute Kidney Injury (AKI) in Patients Undergoing Elective Cardiac Surgery With Cardiopulmonary Bypass (CPB)
This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.
- Conditions
- Acute Kidney Injury
- Being tested
- BCT197 Part A, Placebo, BCT197 Part B
- Keywords
- Acute Kidney Injury, Cardiopulmonary Bypass, CABG, Cardiac Surgery
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCT197 Part ADrug
open label single dose administration of 10mg BCT197, 2 hours prior to surgery
PlaceboDrug
Single dose matching placebo administered 2 prior to surgery
BCT197 Part BDrug
BCT197 50mg single dose administered 2 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Open Label - BCT197 Part A | Experimental | 10mg single dose of BCT197 Receives: Drug: BCT197 Part A |
| BCT197 Part B | Experimental | Single dose of 50mg BCT197 Receives: Drug: BCT197 Part B |
| BCT 197 Placebo Part B | Placebo comparator | Single dose of matching placebo to 50mg BCT197 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function Measured at 48 Hours Post Cardiac Surgery With Cardiopulmonary Bypass Pump.
Median percent change from baseline in estimated Glomerular Filtration Rate (eGFR) at 48 hours postdose.
Measured: 48 hours
Secondary outcomes (1)
Pharmacokinetic Measurements of Drug in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass Pump. Pharmacokinetics Will be Measured Using Cmax
Max serum concentration reached (ng/mL)
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney InjuryStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mereo BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Jacqueline Parkin, PhD FRCP, Study director, Mereo BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336959
- Sponsor's protocol ID
- CBCT197A2202
- Other IDs
- 2011-002735-25
- Status last verified
- Nov 2020
- First submitted
- 13 Apr 2011
- Last updated
- 6 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Randomized, Double-blind, Placebo-controlled, Single Dose Study of BCT197 for the Prevention of Acute Kidney Injury (AKI) in Patients Undergoing Elective Cardiac Surgery With Cardiopulmonary Bypass (CPB)
- ClinicalTrials.gov ID
- NCT01336959
- Acronym / sponsor ID
- CBCT197A2202
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Cardiopulmonary Bypass, CABG, Cardiac Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Mereo BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Posted 8 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of BCT197 on acute kidney injury in patients undergoing cardiac surgery with cardiopulmonary bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Label - BCT197 Part A | Experimental | Drug: BCT197 Part A10mg single dose of BCT197 |
| BCT197 Part B | Experimental | Drug: BCT197 Part BSingle dose of 50mg BCT197 |
| BCT 197 Placebo Part B | Placebo comparator | Drug: PlaceboSingle dose of matching placebo to 50mg BCT197 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective cardiac surgery with CPB. Allowable procedures are CABG alone, aortic valve replacement or repair alone, mitral valve replacement or repair alone, CABG with aortic valve replacement or repair, and CABG with mitral valve replacement or repair. Patients with repeat surgery for any of the procedures can be included.
- Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) 18 kg/m2
- Have an eGFR ≥ 30 and ≤ 60 mL/min/1.73 m2 to participate in Part A, or an eGFR > 60 mL/min/1.73 m2 to participate in Part B. Upon completion of Part A, patients with eGFR ≥ 30 mL/min/1.73 m2 may participate in Part B, with dose administered as per the dosing table
Key exclusion criteria (8 listed)
- left ventricular ejection fraction, in the last 6 months, ≥30%
- Active systemic infection or uncontrolled diabetes mellitus with a glucose ≥250 mg% at the screening assessment
- Pregnant or nursing (lactating) women,
- Female subjects must either:
- have been surgically sterilized or hysterectomized at least 6 months prior to study participation, or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to study participation. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow- up hormone level assessment is she considered not of child bearing potential, Surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF, OR be postmenopausal. Female subjects are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). Female subjects 60 years of age or younger must confirm menopause by the demonstration of a plasma FSH level in the postmenopausal range according to the lab normal range. Documentation of a prior plasma FSH level is acceptable
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 |
|---|---|---|
| BCT197 Part Aopen label single dose administration of 10mg BCT197, 2 hours prior to surgery | Drug | Open Label - BCT197 Part A |
| PlaceboSingle dose matching placebo administered 2 prior to surgery | Drug | BCT 197 Placebo Part B |
| BCT197 Part BBCT197 50mg single dose administered 2 hours prior to surgery | Drug | BCT197 Part B |
Primary outcome
Renal Function Measured at 48 Hours Post Cardiac Surgery With Cardiopulmonary Bypass Pump.
Time frame: 48 hours
Median percent change from baseline in estimated Glomerular Filtration Rate (eGFR) at 48 hours postdose.
1 secondary outcome
Pharmacokinetic Measurements of Drug in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass Pump. Pharmacokinetics Will be Measured Using Cmax
Time frame: 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jacqueline Parkin, PhD FRCP study director
Mereo BioPharma
13 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 BCT197 Part A and BCT197 Part B in people with Acute Kidney Injury, run by Mereo BioPharma at 13 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 3 inclusion and 8 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: stopped early, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Israel, Taiwan. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Renal Function Measured at 48 Hours Post Cardiac Surgery With Cardiopulmonary Bypass Pump. (time frame: 48 hours). 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 6 Nov 2020.