End-stage Renal DiseasePhase 4START-DCDNCT03099122
A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant
A Phase 4 study testing Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus and Methylprednisolone in people with End-stage Renal Disease, run by Sanofi at 1 site in China.
Trial summary
Primary Objective: To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney transplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus and Methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2017to 12 Nov 2019
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Patient is a Chinese recipient of kidney transplant for the first time.
- Patient is a recipient of kidney allograft from Chinese donors donated after cardiac death (including kidney donated after brain death followed by circulatory death).
- Recipient's age is between 18 to 65 years old (including 18 years).
- Donor's age is more than 5 years old.
- Recipient's weight is greater than or equal to 50 kg but less than or equal to 80 kg.
- Patient fully understands the study and signs the informed consent form (ICF) prior to any study procedure.
Who cannot join
- Patient is a multiple organ transplant recipient.
- Recipient with previous kidney or other organ transplant history.
- Recipient and donor have incompatible blood types.
- Recipient and donor have 5 or 6 mismatched human leucocyte antigen (HLA).
- Recipient is known to have an active infection or active chronic infection, or is seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV Ab), or human immunodeficiency virus (HIV). (Serological test results within 12 months before transplantation are acceptable.)
- Recipient with cytomegalovirus (CMV) immunoglobulin G (IgG) negative who receives an allograft from CMV IgG positive donor (CMV IgG [D+/R-]).
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- Any systemic infection requiring continuous treatment at enrolment, but prophylactic treatment of CMV and/or Pneumocystis carinii pneumonia (PCP) is allowed.
- Recipient has severe thrombocytopenia or leucopenia before operation (platelet count <75,000/ul, or the number of white blood cells <3,000 cells/mm3).
- Serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma glutamine transferase (GGT) ≥3ULN (upper limit of normal) within 1 week before transplantation, and not normalized at time of transplantation.
- Recipient has a history of malignancy within 5 years.
- Recipient with history of allergy and anaphylaxes to rabbit proteins or to any excipients.
- Recipient has known contraindications to the administration of Thymoglobuline®.
- Recipient has taken other investigational drugs or prohibited therapy for this study within 1 month or 5 of half-lives from screening, whichever is longer.
- Recipient has previously used Thymoglobuline®, or has participated in any clinical trial of any other medicine or device within 30 days before signing ICF.
- Pregnant or lactating women.
- Male and female patients do not agree to practice medically acceptable contraception (i.e., barrier or pharmacologic: male patient must use condoms or his female partner must take oral contraceptives; the male partner of a female patient must use condoms ) for at least 6 months following the study treatment.
- Conditions/situations such as:
- Recipient not suitable for participation, whatever the reason, as judged by the Investigator, including medical, clinical, or psychosocial conditions, or patient potentially at risk of noncompliance to study procedures.
- Donor known or suspected to have active infection before donation (such as blood cultures positive, seropositive for hepatitis B surface antigen [HBsAg], or antibody against hepatitis C virus [HCVAb], or human immunodeficiency virus [HIV]) or hypersensitive recipients (eg, panel reactive antibody [PRA] positive) before transplantation, judged by the Investigator.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
Primary Objective:
To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney transplant.
Secondary Objectives:
- To evaluate delayed graft function (DGF), graft and patient survival after kidney transplant.
- To evaluate adverse events of Thymoglobuline® throughout the study.
- To explore possible risk factors of AR and DGF in patients with DCD kidney transplant.
- To evaluate AR and DGF under different risk stratifications and explore an description optimal induction therapy regimen for recipients of DCD kidney transplant.
Read the detailed description
The total study duration per patient is 6.5 months.
- Conditions
- End-stage Renal Disease
- Being tested
- Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus, Methylprednisolone, Mycophenolate mofetil, Mycophenolate Na
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabbit Anti-thymocyte ImmunoglobulinBiological
Also called Thymoglobuline
Pharmaceutical form: creamy-white powder
Route of administration: intravenous
TacrolimusDrug
Pharmaceutical form: tablet
Route of administration: oral
Pharmaceutical form: powder
Route of administration: intravenous
Pharmaceutical form: capsule
Route of administration: oral
Mycophenolate NaDrug
Pharmaceutical form: capsule
Route of administration: oral
prednisoneDrug
Pharmaceutical form: tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Thymoglobuline | Experimental | A cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice.
Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies. Receives: Biological: Rabbit Anti-thymocyte Immunoglobulin; Drug: Tacrolimus; Drug: Methylprednisolone; Drug: Mycophenolate mofetil; Drug: Mycophenolate Na; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with biopsy-proven acute rejection events
Measured: 6 months
Secondary outcomes (8)
Percentage of delayed graft function events
Measured: 6 months
Duration of delayed graft function events
Measured: 6 months
Percentage of survived grafts
Measured: 6 months
Percentage of survived patients
Measured: 6 months
Assessment of acute rejection risk factors
Measured: 6 months
Assessment of delayed graft function risk factors
Measured: 6 months
Percentage of acute rejection events in different risk stratifications
Measured: 6 months
Percentage of delayed graft function events in different risk stratifications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start16 Aug 2017
- Primary completion12 Nov 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099122
- Sponsor's protocol ID
- THYMOL07282
- Other IDs
- U1111-1178-5402
- Acronym
- START-DCD
- Status last verified
- Apr 2022
- First submitted
- 29 Mar 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Single-arm, Interventional Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant in China
- ClinicalTrials.gov ID
- NCT03099122
- Acronym / sponsor ID
- START-DCD / THYMOL07282
- Conditions
- End-stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Primary Objective:
To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney transplant.
Secondary Objectives:
- To evaluate delayed graft function (DGF), graft and patient survival after kidney transplant.
- To evaluate adverse events of Thymoglobuline® throughout the study.
- To explore possible risk factors of AR and DGF in patients with DCD kidney transplant.
- To evaluate AR and DGF under different risk stratifications and explore an description optimal induction therapy regimen for recipients of DCD kidney transplant.
Detailed description
The total study duration per patient is 6.5 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thymoglobuline | Experimental | Biological: Rabbit Anti-thymocyte Immunoglobulin, Drug: Tacrolimus, Drug: Methylprednisolone, Drug: Mycophenolate mofetil, Drug: Mycophenolate Na, Drug: prednisoneA cumulative dose of Thymoglobuline will be given intravenously, with a variable interval dose. Methylprednisolone will be given as induction therapy, according to institutional practice. Tacrolimus, mycophenolate, and prednisone will be given as maintenance therapies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female.
- Patient is a Chinese recipient of kidney transplant for the first time.
- Patient is a recipient of kidney allograft from Chinese donors donated after cardiac death (including kidney donated after brain death followed by circulatory death).
- Recipient's age is between 18 to 65 years old (including 18 years).
- Donor's age is more than 5 years old.
Key exclusion criteria (20 listed)
- Patient is a multiple organ transplant recipient.
- Recipient with previous kidney or other organ transplant history.
- Recipient and donor have incompatible blood types.
- Recipient and donor have 5 or 6 mismatched human leucocyte antigen (HLA).
- Recipient is known to have an active infection or active chronic infection, or is seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV Ab), or human immunodeficiency virus (HIV). (Serological test results within 12 months before transplantation are acceptable.)
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 |
|---|---|---|
| Rabbit Anti-thymocyte ImmunoglobulinAlso: ThymoglobulinePharmaceutical form: creamy-white powder Route of administration: intravenous | Biological | Thymoglobuline |
| TacrolimusPharmaceutical form: tablet Route of administration: oral | Drug | Thymoglobuline |
| MethylprednisolonePharmaceutical form: powder Route of administration: intravenous | Drug | Thymoglobuline |
| Mycophenolate mofetilPharmaceutical form: capsule Route of administration: oral | Drug | Thymoglobuline |
| Mycophenolate NaPharmaceutical form: capsule Route of administration: oral | Drug | Thymoglobuline |
| prednisonePharmaceutical form: tablet Route of administration: oral | Drug | Thymoglobuline |
Primary outcome
Percentage of patients with biopsy-proven acute rejection events
Time frame: 6 months
8 secondary outcomes
Percentage of delayed graft function events
Time frame: 6 months
Duration of delayed graft function events
Time frame: 6 months
Percentage of survived grafts
Time frame: 6 months
Percentage of survived patients
Time frame: 6 months
Assessment of acute rejection risk factors
Time frame: 6 months
Assessment of delayed graft function risk factors
Time frame: 6 months
Percentage of acute rejection events in different risk stratifications
Time frame: 6 months
Percentage of delayed graft function events in different risk stratifications
Time frame: 6 months
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 25 Apr 2022.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rabbit Anti-thymocyte Immunoglobulin, Tacrolimus and Methylprednisolone in people with End-stage Renal Disease, run by Sanofi 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 7 inclusion and 20 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 25 Apr 2022. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage of patients with biopsy-proven acute rejection events (time frame: 6 months). 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 25 Apr 2022.