Acute Renal Transplant RejectionPhase 1/2NCT00805909
NI-0401 in Patients With Acute Renal Allograft Rejection
A Phase 1/2 study testing NI-0401 in people with Acute Renal Transplant Rejection, run by Light Chain Bioscience - Novimmune SA at 1 site in France.
Trial summary
The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Renal Transplant Rejection
- What is being tested?
- NI-0401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2007to Jan 2009
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion Criteria:
- evidence of cellular rejection in a renal biopsy according to Bannff 97 criteria
- rise in Serum Creatinine concentration by >20% compared to baseline value
Main Exclusion Criteria:
- previous therapy with anti-CD3 mAB(OKT3) or anti-lymphocytes polyclonal antibodies (ATG, Atgam)
- patients with cardiac insufficiency or fluid overload
- severe HLA sensitization (>50% panel reactive antibodies prior transplantation)
- defined concomitant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa, Open-Label, Dose-Titration, Multicenter Study to Assess the Safety and Preliminary Efficacy of NI-0401 in Patients With Acute Cellular Renal Allograft Rejection
The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.
- Conditions
- Acute Renal Transplant Rejection
- Being tested
- NI-0401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NI-0401Drug
5 daily infusions with escalating doses of NI-0401
| Study group | Role | What they receive |
|---|---|---|
| NI-0401 | Experimental | 5 daily infusions of escalating doses of NI-0401 Receives: Drug: NI-0401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature,frequency,intensity,causality and seriousness of adverse events
Measured: Studay day 1 to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startAug 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal Transplant RejectionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Light Chain Bioscience - Novimmune SA
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805909
- Sponsor's protocol ID
- NI-0401-02
- Status last verified
- Jun 2009
- First submitted
- 8 Dec 2008
- Last updated
- 9 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Open-Label, Dose-Titration, Multicenter Study to Assess the Safety and Preliminary Efficacy of NI-0401 in Patients With Acute Cellular Renal Allograft Rejection
- ClinicalTrials.gov ID
- NCT00805909
- Acronym / sponsor ID
- NI-0401-02
- Conditions
- Acute Renal Transplant Rejection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Light Chain Bioscience - Novimmune SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 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.
The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NI-0401 | Experimental | Drug: NI-04015 daily infusions of escalating doses of NI-0401 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| NI-04015 daily infusions with escalating doses of NI-0401 | Drug | NI-0401 |
Primary outcome
Nature,frequency,intensity,causality and seriousness of adverse events
Time frame: Studay day 1 to week 6
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 9 Jun 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NI-0401 in people with Acute Renal Transplant Rejection, run by Light Chain Bioscience - Novimmune SA at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 combined 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.
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?
Nature,frequency,intensity,causality and seriousness of adverse events (time frame: Studay day 1 to week 6). 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 9 Jun 2009.