Clonal Deletion on Living-Relative Donor Kidney Transplantation

NCT01408797 | Unknown Phase 1 DMC

• 1 other identifier: DAWN-2011-TJM
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to determine if clonal deletion before kidney transplantation can effectively reduce the need for post transplant immunosuppression. The investigators will adapt a DAWN (Drugs (immunosuppressants) Added When Needed) treatment protocol to assess the effect of clonal deletion and closely monitor acute rejection, renal function, and graft survival. 15 patients eligible for the study as described below will be enrolled.

Conditions

Renal Transplantation; Uremia

Keywords

clonal deletion; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Dosage of immunosuppressants

  Effectiveness of clonal deletion on reducing the dosage of immunosuppressants (calcineurin inhibitor plus mycophenolate, azothioprine, or sirolimus).

  one year

Secondary Outcomes (5)

• immune event

  1 year

• DSA

  1 year

• DGF

  1 years

• Renal function

  1 year

• Survival

  1 year

Study Arms (3)

Donor specific transfusion

EXPERIMENTAL

Subjects with uremia will undergo donor specific transfusion before transplantation

Procedure: donor specific transfusion

Clonal deletion

EXPERIMENTAL

Drug: MMF, Bortezomib

Drugs Added When Needed

EXPERIMENTAL

Procedure: drugs added according to the immuno condition of the recipients

Interventions

donor specific transfusion PROCEDURE

before transplantation,200mL of donor whole blood will be transfused to the recipient

Donor specific transfusion

MMF, Bortezomib DRUG

MMF and Bortezomib will be administered after donor specific transfusion

Clonal deletion

drugs added according to the immuno condition of the recipients PROCEDURE

drugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody

Drugs Added When Needed

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old
• Recipients of a kidney from a certifiable relative donor 18-60 years of age
• Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

You may not qualify if:

• Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
• Patient with prior solid organ transplant or cell transplant (e.g. bone marrow or islet cell).
• Patient is deemed likely to have a second solid organ transplant or cell transplant (e.g. bone marrow or islet cell) in next 3 years
• Patient receiving a concurrent SOT (heart, liver, pancreas) or cell transplant (islet, bone marrow, stem cell)
• ABO incompatible donor recipient pair or CDC crossmatch positive transplant
• Sensitized patients (most recent anti-HLA Class I or II Panel Reactive Antibodies (PRA)\>0% by a CDC-assay) or patients identified a high immunological risk by the transplant physician
• Donor with cardiac death (non-heart beating donor)
• Recipient CMV seronegative receiving a organ from a seropositive donor (CMV seromismatch)
• Donor OR Recipient are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
• Donors OR Recipient are known hepatitis B surface antigen-positive or PCR positive for hepatitis B AND recipient is HBV negative
• Patient and/or donors with known human immunodeficiency virus (HIV) infection
• Patient at risk for tuberculosis (TB) Current clinical, radiographic, or laboratory evidence of active or latent TB as determined by local standard of care
• History of active TB:
• Within the last 2 years, even if treated Greater than 2 years ago, unless there is documentation of adequate treatment according to locally accepted clinical practice Patient at risk of reactivation of TB precludes administration of conventional immunosuppression (as determined by investigator and based upon appropriate evaluation)
• Patient with any significant infection or other contraindication that would preclude transplant

Sponsors & Collaborators

• Fuzhou General Hospital: lead
• Terasaki Foundation: collaborator

Study Sites (1)

No. 156, Xi er huan Road

Fuzhou, Fujian, 350025, China

RECRUITING

MeSH Terms

Conditions

Uremia

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Tan Jianming, MD,PhD

  Fuzhou General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tan Jianming, MD,PhD

CONTACT

8613375918000; doctortjm@yahoo.com

Gao Xia, MD

CONTACT

8615959165311; gaojxia@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 3, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 22, 2011

Record last verified: 2011-02

Locations

CN (1)