NCT00805909

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 9, 2009

Status Verified

June 1, 2009

Enrollment Period

1.4 years

First QC Date

December 8, 2008

Last Update Submit

June 8, 2009

Conditions

Acute Renal Transplant Rejection

Outcome Measures

Primary Outcomes (1)

  • Nature,frequency,intensity,causality and seriousness of adverse events

    Studay day 1 to week 6

Study Arms (1)

NI-0401

EXPERIMENTAL

5 daily infusions of escalating doses of NI-0401

Drug: NI-0401

Interventions

NI-0401DRUG

5 daily infusions with escalating doses of NI-0401

NI-0401

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • evidence of cellular rejection in a renal biopsy according to Bannff 97 criteria
  • rise in Serum Creatinine concentration by \>20% compared to baseline value

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker

Paris, 75006, France

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 8, 2008

First Posted

December 10, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 9, 2009

Record last verified: 2009-06

Locations

FR(1)