Kidney DiseasesPhase 1NCT00807794
A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
A Phase 1 study testing MEDI-507 in people with Kidney Diseases, run by MedImmune LLC at 4 sites in United States.
Trial summary
To evaluate the clinical safety of different doses of MEDI-507 through day 33. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- MEDI-507
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 1997to Jan 1998
- Phase
- Phase 1
- 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
- Renal allograft recipients receiving their first or second allograft
- Age over 18
- Maintained on conventional immunosuppression
- Completed informed consent document
Who cannot join
- Known hypersensitivity to MEDI-507
- More than two renal allografts
- Moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial
- Simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert)
- Any of the following clinical settings or diagnoses posttransplant:
- pregnancy or nursing mother: Ø Human Immunodeficiency Virus infection Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator Ø hyperacute rejection
- Having received OKT3, tacrolimus, or antilymphocyte globulin during the current allograft
- Less than 10 ml/hr average urine output over 4 hours since the end of surgery
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University
Bloomington, Indiana, 47405
University of Virginia
Charlottesville, Virginia, 22908
Yale University School of Medicine
New Haven, Connecticut, 06510
San Antonio Community Hospital
San Antonio, Texas, 78229
About this study
Official title: Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
Read the detailed description
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
- Conditions
- Kidney Diseases
- Being tested
- MEDI-507
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-507Drug
0.012 mg/kg dose given twice between 60 to 72 hours apart
MEDI-507Drug
0.06 mg/kg dose given twice between 60 to 72 hours apart
MEDI-507Drug
0.12 mg/kg dose given twice between 60 to 72 hours apart
MEDI-507Drug
0.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
MEDI-507Drug
0.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
| 2 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
| 3 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
| 4 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
| 5 | Experimental | MEDI-507 Receives: Drug: MEDI-507 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.
Measured: Day 33
Secondary outcomes (1)
To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.
Measured: Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startFeb 1997
- Primary completionNov 1997
- Study completionJan 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. Bruce McClain, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807794
- Sponsor's protocol ID
- MI-CP027
- Status last verified
- Dec 2008
- First submitted
- 10 Dec 2008
- Last updated
- 12 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
- ClinicalTrials.gov ID
- NCT00807794
- Acronym / sponsor ID
- MI-CP027
- Conditions
- Kidney Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 1997
- Primary completion
- Nov 1997 (actual)
- Study completion
- Jan 1998 (actual)
- First posted
- 12 Dec 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.
To evaluate the clinical safety of different doses of MEDI-507 through day 33.
Detailed description
To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-507MEDI-507 |
| 2 | Experimental | Drug: MEDI-507MEDI-507 |
| 3 | Experimental | Drug: MEDI-507MEDI-507 |
| 4 | Experimental | Drug: MEDI-507MEDI-507 |
| 5 | Experimental | Drug: MEDI-507MEDI-507 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Renal allograft recipients receiving their first or second allograft
- Age over 18
- Maintained on conventional immunosuppression
- Completed informed consent document
Key exclusion criteria (8 listed)
- Known hypersensitivity to MEDI-507
- More than two renal allografts
- Moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial
- Simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert)
- Any of the following clinical settings or diagnoses posttransplant:
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 |
|---|---|---|
| MEDI-5070.012 mg/kg dose given twice between 60 to 72 hours apart | Drug | 1 |
| MEDI-5070.06 mg/kg dose given twice between 60 to 72 hours apart | Drug | 2 |
| MEDI-5070.12 mg/kg dose given twice between 60 to 72 hours apart | Drug | 3 |
| MEDI-5070.24 mg/kg dose given twice between 60 to 72 hours apart (supplemental) | Drug | 4 |
| MEDI-5070.50 mg/kg dose given twice between 60 to 72 hours apart (supplemental) | Drug | 5 |
Primary outcome
To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.
Time frame: Day 33
1 secondary outcome
To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.
Time frame: Day 33
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 12 Dec 2008.
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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.
J. Bruce McClain, M.D. study director
MedImmune LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-507 in people with Kidney Diseases, run by MedImmune LLC at 4 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 4 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: finished, as of the sponsor's last update on 12 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention. (time frame: Day 33). 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 12 Dec 2008.