Kidney DiseasePhase 1DARTNCT02244801
Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation (The ONE Study )
A Phase 1 study testing darTreg infusion in people with Kidney Disease, run by University of California, San Francisco at 1 site in United States.
Trial summary
This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for adult, de novo, living donor renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Disease
- What is being tested?
- darTreg infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 28 Aug 2018
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for live kidney donation
- At least 18 years of age
- An ABO blood type compatible with the organ recipient
- Willing and able to provide a blood sample for The ONE Study IM (Immune Monitoring) Subproject
- Willing to provide personal and medical/biological data for the trial analysis
- Eligible to give blood for B cell source prior to organ donation
Show all 17Show fewer
- Signed and dated written informed consent*. *For subjects unable to read and/or write, oral informed consent observed by an independent witness is acceptable if the subject has fully understood oral information given by the Investigator. The witness should sign the consent form on behalf of the subject.
- In signing the donor information sheet/informed consent form (DIS/ICF), organ donors agree to undergo phlebotomy to provide donor B cells for the production of darTreg, to provide a blood sample for the IM Subproject, and permit access to their medical records for the collection of specified demographic and medical/biological data for the trial.
- Organ Recipient eligibility:
- A prospective kidney transplant recipient is eligible for enrollment into the study if all of the following inclusion criteria apply:
- Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
- At least 18 years of age
- Able to commence the immunosuppressive regimen at the protocol-specified time point
- Willing and able to participate in The ONE Study IM and HEC (Health-Economics Subproject) subprojects
- Adequate venous access to support leukapheresis
- Signed and dated written informed consent*.
- For patients unable to read and/or write, oral informed consent observed by an independent witness is acceptable if the patient has fully understood oral information given by the Investigator. The witness should sign the consent form on behalf of the patient.
Who cannot join
- If a prospective donor fulfills any of the following criteria, they are ineligible for the trial:
- Genetically identical to the prospective organ recipient at the HLA (human leukocyte antigen) loci (0-0-0 mismatch)
- CMV-positive and donating to a CMV-negative recipient
- Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
Show all 37Show fewer
- Patient has previously received any tissue or organ transplant other than the planned kidney graft
- Known contraindication to the protocol-specified treatments / medications
- Genetically identical to the prospective organ donor at the HLA (human leukocyte antigen) loci (0-0-0 mismatch)
- PRA (panel reactive antibody) grade > 40% within 6 months prior to enrollment
- Previous treatment with any desensitization procedure (with or without IVIg)
- Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin)
- Evidence of significant local or systemic infection
- HIV-positive, EBV-negative or suffering chronic viral hepatitis
- CMV-negative and receiving a kidney from a CMV-positive donor
- Significant liver disease, defined as persistently elevated AST (aspartate aminotransferase) and/or ALT(alanine aminotransferase) levels > 2 x ULN (Upper Limit of Normal range)
- Malignant or pre-malignant hematological conditions
- Neutrophils < 1000/μl ; platelets < 100,000/μl
- Regulatory T cells present in peripheral blood at <30/µL
- Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
- Any condition which, in the judgment of the Investigator, would place the subject at undue risk
- Ongoing treatment with systemic immunosuppressive drugs at study entry
- Patients who have received anti-T cell therapy within 30 days prior to transplant surgery
- Participation in another clinical trial during the study or within 28 days prior to planned study entry
- Female patients of reproductive potential with a positive pregnancy test at enrollment
- Female patients who are breast-feeding
- All female patients of reproductive potential* UNLESS the patient is willing to use an acceptable birth control for the duration of the study unless the patient chooses abstinence (she chooses to avoid heterosexual intercourse completely) (See Table 2. Acceptable Contraception Methods for Females of Reproductive Potential)
- Male patients unwilling to use a reliable and effective form of contraception for 3 months after darTreg dosing
- Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
- Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).
- Females of reproductive potential include girls who have entered puberty and all women who have a uterus and have not passed through menopause. Menopause is the permanent end of menstruation and fertility. Menopause should be clinically confirmed by a patient's healthcare practitioner. Some commonly used diagnostic criteria include 1) 12 months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or 2) postsurgical from a bilateral oophorectomy.
- Below are exclusion criteria to be assessed post-transplantation and prior to darTreg infusion. Subjects who meet any of these criteria should not receive a darTreg-infusion:
- Unacceptable darTreg product.
- Delayed graft function (requiring dialysis post-transplant).
- Requiring oxygen supplementation to keep capillary oxygen saturations >95%.
- Any medical or technical complications (e.g. myocardial infarction, urine leak, wound dehiscence, pneumonia, ongoing fevers, etc.) that in the judgment of the investigators or responsible clinician would put the subject at undue risk.-
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco - Transplant Department. 513 Parnassus Ave HSE 504
San Francisco, California, 94143
About this study
Official title: Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation: A ONE Study Clinical Trial
This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for adult, de novo, living donor renal transplant recipients.
Read the detailed description
A single-center, open-label, dose-escalation pilot trial of a single infusion of darTregs in two dosing cohorts. This study is an independent single-center clinical trial. However, the organizational and mechanistic infrastructure of the study will be provided by the ONE Study project, a European Union funded collaborative project, whose objective is to assess distinct purified hematopoietic immunoregulatory cells as clinical therapies in solid organ transplantation. This study is one of multiple clinical trials within the framework of The ONE Study project, based on the same general design.
- Conditions
- Kidney Disease
- Being tested
- darTreg infusion
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darTreg infusionDrug
Also called darTregs
The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. sBc production for darTreg manufacturing for the second subject in each cohort may be initiated but the second subject may not undergo leukapheresis until the safety review is complete.
Once the last subject in the first cohort reaches week 4 post-infusion, the DSMB will conduct a thorough review of all available data to make a determination about proceeding with additional patients at the lower dose or proceeding to the second dosing cohort. sBc production for darTreg manufacturing for the subsequent subject may be initiated but the patient may not undergo leukapheresis until the DSMB( Data Safety and Monitoring Board ) has approved enrollment of subsequent subjects.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | 3 subjects treated with a target dose of 300 million darTreg with the possibility of expanding to 5 patients if safety signals should require additional patients be observed at the 300 million dose.
The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. Receives: Drug: darTreg infusion |
| Cohort 2 | Other | The second cohort will comprise a minimum of 3 and up to 5 subjects treated at a target dose of 900 million darTreg, depending on how many patients were required to be treated in lower dose group.
The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. Receives: Drug: darTreg infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy-confirmed acute rejection (BCAR) following renal transplantation.
Explore the immunomodulatory potential, safety and tolerability of a single infusion of darTregs as adjunct immunosuppressive treatment through the incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks following renal transplantation.
Measured: 60 weeks post renal transplantation
Secondary outcomes (10)
Time to first acute rejection episode
Measured: 60 weeks post renal transplantation
Severity of acute rejection episodes
severity of acute rejection episodes based on response to treatment and histological scoring
Measured: 60 weeks post renal transplantation
Total immunosuppressive burden at 60 weeks post-transplantation
Total immunosuppressive burden assessed at last study visit
Measured: 60 weeks post renal transplantation
Prevention of chronic graft dysfunction (chronic rejection or IF/TA)
chronic graft dysfunction assessed by clinical (impairment of GFR) and histopathological (Banff staging) measures
Measured: 60 weeks post renal transplantation
Incidence of post-transplant dialysis, inclusion on the transplant waiting list or re-transplantation following graft loss through rejection
Measured: 60 weeks post renal transplantation
Avoidance of drug-related complications by immunosuppressant reduction
Assessed by the incidence of reported adverse drug reactions
Measured: 60 weeks post renal transplantation
Biochemical disturbances caused by cell infusion
Assessed by Incidence of acute toxicities associated with infusion of the cell product
Measured: 1 week
Over-suppression of the immune system assessed by the incidence of major and/or opportunistic infections especially CMV (cytomegalovirus ), EBV (Epstein-Barr virus) and polyoma virus
Measured: 60 weeks post renal transplantation
Incidence of neoplasia
Measured: 60 weeks post renal transplantation
Incidence of patients treated for subclinical acute rejection
Measured: 60 weeks post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startApr 2015
- Primary completionSep 2017
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Seventh Framework Programme
- Responsible party
- Principal investigator, Sang-Mo Kang, University of California, San Francisco
- Investigators
- Sang-Mo Kang, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244801
- Sponsor's protocol ID
- ONEdarTreg14
- Acronym
- DART
- Status last verified
- Oct 2018
- First submitted
- 11 Sep 2014
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med. 1999 Aug 15;18(15):1905-42. No abstract available.
PubMed 10532877Francillon A, Pickering G, Belorgey C. Exploratory clinical trials: implementation modes & guidelines, scope and regulatory framework. Therapie. 2009 May-Jun;64(3):149-59. doi: 10.2515/therapie/2009022. Epub 2009 Aug 13. English, French.
PubMed 19671427Morris PJ. Transplantation--a medical miracle of the 20th century. N Engl J Med. 2004 Dec 23;351(26):2678-80. doi: 10.1056/NEJMp048256. No abstract available.
PubMed 15616201Sayegh MH, Carpenter CB. Transplantation 50 years later--progress, challenges, and promises. N Engl J Med. 2004 Dec 23;351(26):2761-6. doi: 10.1056/NEJMon043418. No abstract available.
PubMed 15616214Gibson T, Medawar PB. The fate of skin homografts in man. J Anat. 1943 Jul;77(Pt 4):299-310.4. No abstract available.
PubMed 17104936Medawar PB. The behaviour and fate of skin autografts and skin homografts in rabbits: A report to the War Wounds Committee of the Medical Research Council. J Anat. 1944 Oct;78(Pt 5):176-99. No abstract available.
PubMed 17104960Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med. 2004 Dec 23;351(26):2715-29. doi: 10.1056/NEJMra033540. No abstract available.
PubMed 15616206MERRILL JP, MURRAY JE, HARRISON JH, GUILD WR. Successful homotransplantation of the human kidney between identical twins. J Am Med Assoc. 1956 Jan 28;160(4):277-82. doi: 10.1001/jama.1956.02960390027008. No abstract available.
PubMed 13278189Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Boger CA, Scotta C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Ollinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyo J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7.
PubMed 32446407
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation: A ONE Study Clinical Trial
- ClinicalTrials.gov ID
- NCT02244801
- Acronym / sponsor ID
- DART / ONEdarTreg14
- Conditions
- Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Seventh Framework Programme
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 19 Sep 2014 (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.
This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for adult, de novo, living donor renal transplant recipients.
Detailed description
A single-center, open-label, dose-escalation pilot trial of a single infusion of darTregs in two dosing cohorts. This study is an independent single-center clinical trial. However, the organizational and mechanistic infrastructure of the study will be provided by the ONE Study project, a European Union funded collaborative project, whose objective is to assess distinct purified hematopoietic immunoregulatory cells as clinical therapies in solid organ transplantation. This study is one of multiple clinical trials within the framework of The ONE Study project, based on the same general design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: darTreg infusion3 subjects treated with a target dose of 300 million darTreg with the possibility of expanding to 5 patients if safety signals should require additional patients be observed at the 300 million dose. The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. |
| Cohort 2 | Other | Drug: darTreg infusionThe second cohort will comprise a minimum of 3 and up to 5 subjects treated at a target dose of 900 million darTreg, depending on how many patients were required to be treated in lower dose group. The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Eligible for live kidney donation
- At least 18 years of age
- An ABO blood type compatible with the organ recipient
- Willing and able to provide a blood sample for The ONE Study IM (Immune Monitoring) Subproject
- Willing to provide personal and medical/biological data for the trial analysis
Key exclusion criteria (37 listed)
- If a prospective donor fulfills any of the following criteria, they are ineligible for the trial:
- Genetically identical to the prospective organ recipient at the HLA (human leukocyte antigen) loci (0-0-0 mismatch)
- CMV-positive and donating to a CMV-negative recipient
- Exposure to any investigational agents at the time of kidney donation, or within 28 days prior to kidney donation
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
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 |
|---|---|---|
| darTreg infusionAlso: darTregsThe first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. sBc production for darTreg manufacturing for the second subject in each cohort may be initiated but the second subject may not undergo leukapheresis until the safety review is complete. Once the last subject in the first cohort reaches week 4 post-infusion, the DSMB will conduct a thorough review of all available data to make a determination about proceeding with additional patients at the lower dose or proceeding to the second dosing cohort. sBc production for darTreg manufacturing for the subsequent subject may be initiated but the patient may not undergo leukapheresis until the DSMB( Data Safety and Monitoring Board ) has approved enrollment of subsequent subjects. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Incidence of biopsy-confirmed acute rejection (BCAR) following renal transplantation.
Time frame: 60 weeks post renal transplantation
Explore the immunomodulatory potential, safety and tolerability of a single infusion of darTregs as adjunct immunosuppressive treatment through the incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks following renal transplantation.
10 secondary outcomes
Time to first acute rejection episode
Time frame: 60 weeks post renal transplantation
Severity of acute rejection episodes
Time frame: 60 weeks post renal transplantation
Total immunosuppressive burden at 60 weeks post-transplantation
Time frame: 60 weeks post renal transplantation
Prevention of chronic graft dysfunction (chronic rejection or IF/TA)
Time frame: 60 weeks post renal transplantation
Incidence of post-transplant dialysis, inclusion on the transplant waiting list or re-transplantation following graft loss through rejection
Time frame: 60 weeks post renal transplantation
Avoidance of drug-related complications by immunosuppressant reduction
Time frame: 60 weeks post renal transplantation
Biochemical disturbances caused by cell infusion
Time frame: 1 week
Over-suppression of the immune system assessed by the incidence of major and/or opportunistic infections especially CMV (cytomegalovirus ), EBV (Epstein-Barr virus) and polyoma virus
Time frame: 60 weeks post renal transplantation
Incidence of neoplasia
Time frame: 60 weeks post renal transplantation
Incidence of patients treated for subclinical acute rejection
Time frame: 60 weeks post transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 10532877ICH Harmonised Tripartite Guideline. Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med. 1999 Aug 15;18(15):1905-42. No abstract available.
- Background: PubMed 19671427Francillon A, Pickering G, Belorgey C. Exploratory clinical trials: implementation modes & guidelines, scope and regulatory framework. Therapie. 2009 May-Jun;64(3):149-59. doi: 10.2515/therapie/2009022. Epub 2009 Aug 13. English, French.
- Background: PubMed 15616201Morris PJ. Transplantation--a medical miracle of the 20th century. N Engl J Med. 2004 Dec 23;351(26):2678-80. doi: 10.1056/NEJMp048256. No abstract available.
- Background: PubMed 15616214Sayegh MH, Carpenter CB. Transplantation 50 years later--progress, challenges, and promises. N Engl J Med. 2004 Dec 23;351(26):2761-6. doi: 10.1056/NEJMon043418. No abstract available.
- Background: PubMed 17104936Gibson T, Medawar PB. The fate of skin homografts in man. J Anat. 1943 Jul;77(Pt 4):299-310.4. No abstract available.
- Background: PubMed 17104960Medawar PB. The behaviour and fate of skin autografts and skin homografts in rabbits: A report to the War Wounds Committee of the Medical Research Council. J Anat. 1944 Oct;78(Pt 5):176-99. No abstract available.
- Background: PubMed 15616206Halloran PF. Immunosuppressive drugs for kidney transplantation. N Engl J Med. 2004 Dec 23;351(26):2715-29. doi: 10.1056/NEJMra033540. No abstract available.
- Results publication: PubMed 13278189MERRILL JP, MURRAY JE, HARRISON JH, GUILD WR. Successful homotransplantation of the human kidney between identical twins. J Am Med Assoc. 1956 Jan 28;160(4):277-82. doi: 10.1001/jama.1956.02960390027008. No abstract available.
- Derived from this study: PubMed 32446407Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Boger CA, Scotta C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Ollinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyo J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7.
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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.
Sang-Mo Kang, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing darTreg infusion in people with Kidney Disease, run by University of California, San Francisco at 1 site in United States.
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 17 inclusion and 37 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: finished, as of the sponsor's last update on 15 Oct 2018. 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 United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of biopsy-confirmed acute rejection (BCAR) following renal transplantation. (time frame: 60 weeks post renal transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02244801, which also lists 9 linked publications.
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 15 Oct 2018.