Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant

End Stage Renal Disease Clinical Trial

Official title:

Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01502267
• Other study ID #: 11374
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: December 24, 2011
• Last updated: January 5, 2012
• Start date: January 2010
• Est. completion date: January 2016

Study information

• Verified date: January 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

HLA sensitization is known to be the most important barrier to deceased donor kidney allocation. Therefore, the investigators need to develop better strategies for managing pre-sensitized patients using desensitization protocol. In this study the investigators will used two kinds of medication for the reduction of circulating antibodies (high dose IVIg, B cell depleting agents) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplantation. After desensitization, the investigators will check that this treatment can increase their chances of receiving a kidney transplant.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18

• patients who are on the waiting list more than 4 years

• PRA I or II > 50%

Exclusion Criteria:

• 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• High dose IVIG and B cell depleting agents
IVIG(2g/kg two times on day 1, 30) Rituximab(375mg/m2 on day 3) Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rates of kidney transplantation		from one to five years	No
Secondary	Reduction in anti-HLA alloantibodies		1year	No
Secondary	Renal allograft survival	graft and patient survival	from one to five year	No
Secondary	The number of serious complication		from one to five year	Yes

External Links

•   Korea Food and Drug Administration