Kidney TransplantationPhase 2NCT00615966
Phase 2 Study of the Safety of Diannexin in Kidney Transplant Recipients
A Phase 2 study testing Diannexin in people with Kidney Transplantation, run by Alavita Pharmaceuticals Inc at 5 sites in United States.
Trial summary
The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Diannexin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2008to Feb 2010
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to receive a kidney transplant from a deceased expanded criterion donor (ECD) or a donor cardiac death (DCD) donor that was exposed to no more than 36 hr of cold ischemia prior to transplantation, or scheduled to receive a kidney transplant from a standard criterion donor (SCD) that was exposed to 24-36 hr of cold ischemia prior to transplantation
- Willing to use adequate contraception for at least 4 weeks after dosing
- Willing and able to provide written Informed Consent and to comply with the requirements of the study
Who cannot join
- If female, subject is pregnant or lactating
- Known bleeding diathesis
- INR at Screening > 1.5
- Platelet count at Screening below LLN and judged clinically significant
- Use of Plavix, anticoagulants other than aspirin, antithrombotics, and/or blood-thinning agents within 10 days prior to study entry
- Previous receipt of an organ transplant
Show all 16Show fewer
- Will receive concurrent transplant of any additional organ(s)
- Clinically significant active infection at study entry
- Surgery within 2 weeks prior to study entry
- Believed to have used an illicit drug and/or abused alcohol within 3 months prior to study entry
- Presence of a psychiatric illness that might interfere with study participation
- Cancer, other than basal cell or squamous cell cancer of the skin, within 2 years prior to study entry
- Scheduled to receive a kidney transplant from a low risk donor
- Currently participation, or participated within 30 days prior to study entry, in an investigational drug study
- Known allergy to kanamycin
- History or presence of any medical condition or disease that could place the subject an unacceptable risk for study participation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Maryland
Baltimore, Maryland, 21201
St Barnabas Medical Center
Livingston, New Jersey, 07039
University of Wisconsin Medical School, Dept of Surgery
Madison, Wisconsin, 53792
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: A Phase 2, Two-Part Study of the Safety and Tolerability of Diannexin in Kidney Transplant Recipients
The purpose of this study is evaluate the safety and tolerability of Diannexin in kidney transplant recipients.
Read the detailed description
Ischemia-reperfusion injury, which occurs when the blood supply to an organ, or part of an organ, is cut off and subsequently restored, is an important clinical problem in the organ transplant setting. Diannexin, a recombinant form of the endogenous human Annexin V protein, is in development as a therapeutic agent designed to prevent ischemia-reperfusion injury following organ transplantation. Pharmacology studies indicate that Diannexin has protective effect in various ischemia-reperfusion injury and organ transplantation models. Diannexin binds to phosphatidylserine on cell surfaces, which is believed to underlie its ability to attenuate ischemia-reperfusion injury. In a completed Phase 1 trial, Diannexin was judged safe and well tolerated in healthy adult subjects. The present study is designed to determine the safety and tolerability of single escalating doses of Diannexin in kidney transplant recipients.
- Conditions
- Kidney Transplantation
- Being tested
- Diannexin, Placebo
- Keywords
- kidney transplantation, ischemia-reperfusion injury, phosphatidylserine binding
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiannexinDrug
single dose, 200 µg/kg IV
PlaceboDrug
Single dose, IV
DiannexinDrug
Single dose, 400 µg/kg IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Diannexin |
| 2 | Experimental | Not described Receives: Drug: Diannexin |
| 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events
Measured: 28 days following administration of study medication
Secondary outcomes (1)
Population pharmacokinetics
Measured: Through Hour 48 after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alavita Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Investigators
- Stuart Knechtle, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615966
- Sponsor's protocol ID
- DAV-CL002
- Status last verified
- Jun 2011
- First submitted
- 1 Feb 2008
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cheng EY, Sharma VK, Chang C, Ding R, Allison AC, Leeser DB, Suthanthiran M, Yang H. Diannexin decreases inflammatory cell infiltration into the islet graft, reduces beta-cell apoptosis, and improves early graft function. Transplantation. 2010 Oct 15;90(7):709-16. doi: 10.1097/TP.0b013e3181ed55d8.
PubMed 20634785
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Two-Part Study of the Safety and Tolerability of Diannexin in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT00615966
- Acronym / sponsor ID
- DAV-CL002
- Conditions
- Kidney Transplantation
- Keywords
- kidney transplantation, ischemia-reperfusion injury, phosphatidylserine binding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Alavita Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 14 Feb 2008 (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 purpose of this study is evaluate the safety and tolerability of Diannexin in kidney transplant recipients.
Detailed description
Ischemia-reperfusion injury, which occurs when the blood supply to an organ, or part of an organ, is cut off and subsequently restored, is an important clinical problem in the organ transplant setting. Diannexin, a recombinant form of the endogenous human Annexin V protein, is in development as a therapeutic agent designed to prevent ischemia-reperfusion injury following organ transplantation. Pharmacology studies indicate that Diannexin has protective effect in various ischemia-reperfusion injury and organ transplantation models. Diannexin binds to phosphatidylserine on cell surfaces, which is believed to underlie its ability to attenuate ischemia-reperfusion injury. In a completed Phase 1 trial, Diannexin was judged safe and well tolerated in healthy adult subjects. The present study is designed to determine the safety and tolerability of single escalating doses of Diannexin in kidney transplant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Diannexin |
| 2 | Experimental | Drug: Diannexin |
| 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to receive a kidney transplant from a deceased expanded criterion donor (ECD) or a donor cardiac death (DCD) donor that was exposed to no more than 36 hr of cold ischemia prior to transplantation, or scheduled to receive a kidney transplant from a standard criterion donor (SCD) that was exposed to 24-36 hr of cold ischemia prior to transplantation
- Willing to use adequate contraception for at least 4 weeks after dosing
- Willing and able to provide written Informed Consent and to comply with the requirements of the study
Key exclusion criteria (16 listed)
- If female, subject is pregnant or lactating
- Known bleeding diathesis
- INR at Screening > 1.5
- Platelet count at Screening below LLN and judged clinically significant
- Use of Plavix, anticoagulants other than aspirin, antithrombotics, and/or blood-thinning agents within 10 days prior to study entry
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 |
|---|---|---|
| Diannexinsingle dose, 200 µg/kg IV | Drug | 1 |
| PlaceboSingle dose, IV | Drug | 3 |
| DiannexinSingle dose, 400 µg/kg IV | Drug | 2 |
Primary outcome
Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events
Time frame: 28 days following administration of study medication
1 secondary outcome
Population pharmacokinetics
Time frame: Through Hour 48 after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
- Derived from this study: PubMed 20634785Cheng EY, Sharma VK, Chang C, Ding R, Allison AC, Leeser DB, Suthanthiran M, Yang H. Diannexin decreases inflammatory cell infiltration into the islet graft, reduces beta-cell apoptosis, and improves early graft function. Transplantation. 2010 Oct 15;90(7):709-16. doi: 10.1097/TP.0b013e3181ed55d8.
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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.
Stuart Knechtle, MD principal investigator
Emory University
5 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 Diannexin in people with Kidney Transplantation, run by Alavita Pharmaceuticals Inc at 5 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 3 inclusion and 16 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: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety assessments -- physical examinations, vital signs, clinical safety laboratory tests, ECGs, immunogenicity testing, adverse events (time frame: 28 days following administration of study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00615966, which also lists 1 linked publication.
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 29 Jun 2011.