Renal TransplantationPhase 1/2DAWNNCT01408797
Clonal Deletion on Living-Relative Donor Kidney Transplantation
A Phase 1/2 study testing donor specific transfusion, MMF, Bortezomib and drugs added according to the immuno condition of the recipients in people with Renal Transplantation and Uremia, run by Fuzhou General Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Renal Transplantation, Uremia
- What is being tested?
- donor specific transfusion, MMF, Bortezomib and drugs added according to the immuno condition of the recipients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Mar 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
No. 156, Xi er huan Road
Fuzhou, Fujian, 350025
Tan Jianming, MD,PhD, 8613375918000, doctortjm@yahoo.com
Gao Xia, MD, 8615959165311, gaojxia@yahoo.com.cn
About this study
Official title: A Prospective, Open-Label, Pilot Study of Clonal Deletion on Living-Relative Donor Kidney Transplantation
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.
Read the detailed description
The objective of this trial is to determine if clonal deletion can effectively reduce the need for post transplant immunosuppressive medicine. Emphasis will be placed on adverse events that are associated with clonal deletion. The investigators will assess whether DAWN (Drugs (immunosuppressants) Added When Needed) is feasible in living-relative donor kidney transplantation and the effectiveness of clonal deletion treatment on the rate of rejection, patient survival, and graft function from day 0 to 12 months after transplantation. Numbers of patients on single drug and dual therapy immunosuppression will be counted. Additionally, the investigators would assess time to immune event (rejection or antibody), the severity of acute rejection or antibody mediated rejection by Banff criteria, the incidence of delayed graft function (defined as the need for post-transplant dialysis), and the incidence of adverse events including infection, grade 3 and above non-hematologic toxicities, and grade 4 hematologic toxicities.
- Conditions
- Renal Transplantation, Uremia
- Being tested
- donor specific transfusion, MMF, Bortezomib, drugs added according to the immuno condition of the recipients
- Keywords
- clonal deletion, kidney transplantation
- Medical subject headings
- Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor specific transfusionProcedure or surgery
before transplantation,200mL of donor whole blood will be transfused to the recipient
MMF, BortezomibDrug
MMF and Bortezomib will be administered after donor specific transfusion
drugs added according to the immuno condition of the recipientsProcedure or surgery
drugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody
| Study group | Role | What they receive |
|---|---|---|
| Donor specific transfusion | Experimental | Subjects with uremia will undergo donor specific transfusion before transplantation Receives: Procedure: donor specific transfusion |
| Clonal deletion | Experimental | Not described Receives: Drug: MMF, Bortezomib |
| Drugs Added When Needed | Experimental | Not described Receives: Procedure: drugs added according to the immuno condition of the recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of immunosuppressants
Effectiveness of clonal deletion on reducing the dosage of immunosuppressants (calcineurin inhibitor plus mycophenolate, azothioprine, or sirolimus).
Measured: one year
Secondary outcomes (5)
immune event
Time to immune event (acute rejection or DSA);
Measured: 1 year
DSA
Proportion of patients who become positive for donor specific HLA antibodies post transplant
Measured: 1 year
DGF
Incidence of delayed graft function (defined as need for post-transplant dialysis)
Measured: 1 years
Renal function
Change in renal function as determined by estimated glomerular filtration rate and proteinuria (>1g) at 1 year post transplant
Measured: 1 year
Survival
Allograft Survival at 1 year post transplant
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Terasaki Foundation
- Investigators
- Tan Jianming, MD,PhD, Principal investigator, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408797
- Sponsor's protocol ID
- DAWN-2011-TJM
- Acronym
- DAWN
- Status last verified
- Feb 2011
- First submitted
- 2 Aug 2011
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Pilot Study of Clonal Deletion on Living-Relative Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01408797
- Acronym / sponsor ID
- DAWN / DAWN-2011-TJM
- Conditions
- Renal Transplantation, Uremia
- Keywords
- clonal deletion, kidney transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Collaborators
- Terasaki Foundation
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this trial is to determine if clonal deletion can effectively reduce the need for post transplant immunosuppressive medicine. Emphasis will be placed on adverse events that are associated with clonal deletion. The investigators will assess whether DAWN (Drugs (immunosuppressants) Added When Needed) is feasible in living-relative donor kidney transplantation and the effectiveness of clonal deletion treatment on the rate of rejection, patient survival, and graft function from day 0 to 12 months after transplantation. Numbers of patients on single drug and dual therapy immunosuppression will be counted. Additionally, the investigators would assess time to immune event (rejection or antibody), the severity of acute rejection or antibody mediated rejection by Banff criteria, the incidence of delayed graft function (defined as the need for post-transplant dialysis), and the incidence of adverse events including infection, grade 3 and above non-hematologic toxicities, and grade 4 hematologic toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Donor specific transfusion | Experimental | Procedure: donor specific transfusionSubjects with uremia will undergo donor specific transfusion before transplantation |
| Clonal deletion | Experimental | Drug: MMF, Bortezomib |
| Drugs Added When Needed | Experimental | Procedure: drugs added according to the immuno condition of the recipients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donor specific transfusionbefore transplantation,200mL of donor whole blood will be transfused to the recipient | Procedure or surgery | Donor specific transfusion |
| MMF, BortezomibMMF and Bortezomib will be administered after donor specific transfusion | Drug | Clonal deletion |
| drugs added according to the immuno condition of the recipientsdrugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody | Procedure or surgery | Drugs Added When Needed |
Primary outcome
Dosage of immunosuppressants
Time frame: one year
Effectiveness of clonal deletion on reducing the dosage of immunosuppressants (calcineurin inhibitor plus mycophenolate, azothioprine, or sirolimus).
5 secondary outcomes
immune event
Time frame: 1 year
DSA
Time frame: 1 year
DGF
Time frame: 1 years
Renal function
Time frame: 1 year
Survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tan Jianming, MD,PhD principal investigator
Fuzhou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing donor specific transfusion, MMF, Bortezomib and drugs added according to the immuno condition of the recipients in people with Renal Transplantation and Uremia, run by Fuzhou General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tan Jianming, MD,PhD (8613375918000, doctortjm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of immunosuppressants (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.