Clonal Deletion on Living-Relative Donor Kidney Transplantation (DAWN)
A Prospective, Open-Label, Pilot Study of Clonal Deletion on Living-Relative Donor Kidney Transplantation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Tan Jianming, MD,PhD
- Phone Number: 8613375918000
- Email: doctortjm@yahoo.com
Study Contact Backup
- Name: Gao Xia, MD
- Phone Number: 8615959165311
- Email: gaojxia@yahoo.com.cn
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350025
- Recruiting
- No. 156, Xi er huan Road
-
Contact:
- Tan Jianming, MD,PhD
- Phone Number: 8613375918000
- Email: doctortjm@yahoo.com
-
Contact:
- Gao Xia, MD
- Phone Number: 8615959165311
- Email: gaojxia@yahoo.com.cn
-
Principal Investigator:
- Tan Jianming, MD,PhD
-
Principal Investigator:
- Gao Xia, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patient with a history of hypercoaguable state
- Patient with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not compatible with adequate study follow-up.
- Patient with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal malabsorption
- Patient with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted)
- Patient with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy
- Patient with a hypersensitivity to any study drugs
- Patient who have used any investigational drug within 30 days prior to the Day 1 visit
- . Patients with autoimmune disease or patient treated with immunosuppressive therapy (eg methotrexate, abatacept, etc) for indications such as autoimmune disease or patient with comorbidity to a degree that treatment with such agents is likely during the trial
- Prisoner or patient compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Donor specific transfusion
Subjects with uremia will undergo donor specific transfusion before transplantation
|
before transplantation,200mL of donor whole blood will be transfused to the recipient
|
|
Experimental: Clonal deletion
|
MMF and Bortezomib will be administered after donor specific transfusion
|
|
Experimental: Drugs Added When Needed
|
drugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dosage of immunosuppressants
Time Frame: one year
|
Effectiveness of clonal deletion on reducing the dosage of immunosuppressants (calcineurin inhibitor plus mycophenolate, azothioprine, or sirolimus).
|
one year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
immune event
Time Frame: 1 year
|
Time to immune event (acute rejection or DSA);
|
1 year
|
|
DSA
Time Frame: 1 year
|
Proportion of patients who become positive for donor specific HLA antibodies post transplant
|
1 year
|
|
DGF
Time Frame: 1 years
|
Incidence of delayed graft function (defined as need for post-transplant dialysis)
|
1 years
|
|
Renal function
Time Frame: 1 year
|
Change in renal function as determined by estimated glomerular filtration rate and proteinuria (>1g) at 1 year post transplant
|
1 year
|
|
Survival
Time Frame: 1 year
|
Allograft Survival at 1 year post transplant
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Tan Jianming, MD,PhD, Fuzhou General Hospital
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- DAWN-2011-TJM
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