NI-0401 in Patients With Acute Renal Allograft Rejection | NCT00805909

Studies
NI-0401 in Patients With Acute Renal Allograft Rejection

NCT00805909

Sponsor

Light Chain Bioscience - Novimmune SA

Status

Completed

Last Update Posted

Jun 9, 2009Estimated

Enrollment

12Estimated

Phase

Phase 1Phase 2

Conditions

Acute Renal Transplant Rejection

Interventions

NI-0401

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Dec 8, 2008

First Submission Date that Met QC Criteria

Dec 9, 2008

First Posted Date

Dec 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2009

Last Update Posted Date

Jun 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NI-0401	Experimental	5 daily infusions of escalating doses of NI-0401	Drug: NI-0401

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NI-0401	Drug	5 daily infusions with escalating doses of NI-0401	NI-0401

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nature,frequency,intensity,causality and seriousness of adverse events		Studay day 1 to week 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Necker		Paris		75006	France