Thymoglobulin DosePhase 4NCT03088280
Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen
A Phase 4 study testing Thymoglobulin in people with Thymoglobulin Dose, run by Hospital Geral de Fortaleza at 1 site in Brazil.
Trial summary
Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymoglobulin Dose
- What is being tested?
- Thymoglobulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2015to Jan 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary kidney transplant recipients, adults
Who cannot join
- PRA > 50%
- DSA > 1500 MFI
- Retransplantation
- Patients who are planning to receive mycophenolate instead of everolimus
- Patients who have planning for follow-up in another center
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Transplant ward of the Hospital do Fortaleza
Fortaleza, Ceará, 60175-205
About this study
Official title: Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen
Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.
- Conditions
- Thymoglobulin Dose
- Being tested
- Thymoglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinDrug
reduced dose (3mg/Kg)
| Study group | Role | What they receive |
|---|---|---|
| 3mg/kg Group | Experimental | Patients will received Thymoglobuline 3mg/Kg (reduced dose) Receives: Drug: Thymoglobulin |
| 6mg/kg Group | Active comparator | Patients will received Thymoglobuline 6mg/Kg (standard dose) Receives: Drug: Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute rejection
Biopsy proven and all treated acute rejection episodes
Measured: 1 year
Secondary outcomes (1)
Infection
All infections requiring hospitalization
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 posted23 Mar 2017
- Study start30 Jun 2015
- Primary completion10 Jan 2018
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymoglobulin DoseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Geral de Fortaleza
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tainá Veras de Sandes Freitas, Hospital Geral de Fortaleza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088280
- Sponsor's protocol ID
- 01
- Status last verified
- Feb 2019
- First submitted
- 17 Mar 2017
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient data are confidential e will not be share with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen
- ClinicalTrials.gov ID
- NCT03088280
- Acronym / sponsor ID
- 01
- Conditions
- Thymoglobulin Dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Geral de FortalezaOther government
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- Jan 2020 (estimated)
- First posted
- 23 Mar 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.
Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3mg/kg Group | Experimental | Drug: ThymoglobulinPatients will received Thymoglobuline 3mg/Kg (reduced dose) |
| 6mg/kg Group | Active comparator | Drug: ThymoglobulinPatients will received Thymoglobuline 6mg/Kg (standard dose) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary kidney transplant recipients, adults
Key exclusion criteria (5 listed)
- PRA > 50%
- DSA > 1500 MFI
- Retransplantation
- Patients who are planning to receive mycophenolate instead of everolimus
- Patients who have planning for follow-up in another center
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 |
|---|---|---|
| Thymoglobulinreduced dose (3mg/Kg) | Drug | 3mg/kg Group, 6mg/kg Group |
Primary outcome
Acute rejection
Time frame: 1 year
Biopsy proven and all treated acute rejection episodes
1 secondary outcome
Infection
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 Feb 2019.
- Individual participant dataSharing planned: No. patient data are confidential e will not be share with other researchers.
Related trials for Thymoglobulin Dose
RecruitingPhase 2
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Renal Transplant Failure and Rejection
Active, not recruitingPhase 2
A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant
Acute Myeloid Leukemia (AML), Acute Lymphoid Leukemia (ALL)
Active, not recruitingPhase 2
Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases
Autoimmune Disease, Neurologic Autoimmune Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thymoglobulin in people with Thymoglobulin Dose, run by Hospital Geral de Fortaleza at 1 site in Brazil.
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 1 inclusion and 5 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 Feb 2019. 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 Brazil. 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?
Results are not available in the source record.
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?
Acute rejection (time frame: 1 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 Feb 2019.