NCT01502267

Brief Summary

The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

4 years

First QC Date

December 24, 2011

Last Update Submit

January 5, 2012

Conditions

End Stage Renal Disease

Keywords

Waiting listDeceased donor kidney transplantationDesensitizationanti HLA antibody

Outcome Measures

Primary Outcomes (1)

  • The rates of kidney transplantation

    from one to five years

Secondary Outcomes (3)

  • Reduction in anti-HLA alloantibodies

    1year

  • Renal allograft survival

    from one to five year

  • The number of serious complication

    from one to five year

Study Arms (2)

Group 1

NO INTERVENTION

This group will not receive IVIG and B cell depleting agents

Group 2

EXPERIMENTAL

This group will receive IVIG and B cell depleting agents

Drug: High dose IVIG and B cell depleting agents

Interventions

High dose IVIG and B cell depleting agentsDRUG

1. IVIG(2g/kg two times on day 1, 30) 2. Rituximab(375mg/m2 on day 3) 3. Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41)

Also known as: IVIG, Mabthera, Velcade
Group 2

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18
  • patients who are on the waiting list more than 4 years
  • PRA I or II \> 50%

You may not qualify if:

  • Recent recipients of any live attenuated vaccine(s) within 4 weeks
  • Subjects who have received IVIG or B cell depleting agents previously
  • Subjects with positive result for viral hepatitis(B,C) or HIV infection
  • Subjects with active infection
  • Lactating or pregnant females
  • Subjects who have history of malignancy in recent 5years
  • Subjects who have experience of treatment for the psychiatric problem in recent 6months
  • Subjects who have hematologic abnormality (Hb \< 7g/dL, Platelet \< 100,000/mm3, AST/ALT \> 80IU)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-799, South Korea

Location

Related Publications (1)

  • Jeong JC, Jambaldorj E, Kwon HY, Kim MG, Im HJ, Jeon HJ, In JW, Han M, Koo TY, Chung J, Song EY, Ahn C, Yang J. Desensitization Using Bortezomib and High-dose Immunoglobulin Increases Rate of Deceased Donor Kidney Transplantation. Medicine (Baltimore). 2016 Feb;95(5):e2635. doi: 10.1097/MD.0000000000002635.

    PMID: 26844479DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Immunoglobulins, IntravenousRituximabBortezomib

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Curie Ahn, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2011

First Posted

December 30, 2011

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2016

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

KR(1)