Kidney TransplantPhase 4NCT01802268
Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients
A Phase 4 study testing Conversion from Tacrolimus to Sirolimus and Maintenance on tacrolimus in people with Kidney Transplant, run by Helio Tedesco Silva Junior at 6 sites in Brazil.
Trial summary
Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Conversion from Tacrolimus to Sirolimus and Maintenance on tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 6 sitesBrazil
- Study dates
- Feb 2008to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older than 18 years,
- recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,
- patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,
- all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.
Who cannot join
- patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,
- patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,
- patients with previous history of malignancy,
- patients with significant hematological or metabolic laboratorial abnormalities.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil
Curitiba, Paraná
Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
Porto Alegre, Rio Grande do Sul
Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro
Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, Brazil
São Jose Do Rio Preto, São Paulo, 04038
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
São Paulo, São Paulo, 04038
Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, Brazil.
São Paulo, São Paulo, 04038
About this study
Official title: Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients
Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.
This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.
- Conditions
- Kidney Transplant
- Being tested
- Conversion from Tacrolimus to Sirolimus, Maintenance on tacrolimus
- Keywords
- sirolimus, tacrolimus, early conversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conversion from Tacrolimus to SirolimusDrug
Maintenance on tacrolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus | Active comparator | Conversion from Tacrolimus to Sirolimus Receives: Drug: Conversion from Tacrolimus to Sirolimus |
| Tacrolimus | Active comparator | Maintenance on tacrolimus Receives: Drug: Maintenance on tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Function calculated using the 4 variable MDRD formula
Measured: 24 months
Secondary outcomes (6)
Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.
Measured: 24 months
Incidence of all treated acute rejections.
Measured: 24 months
Incidence and severity of all tBCAR.
Measured: 24 months
Patient and graft survival.
Measured: 24 months
Incidence of treatment discontinuation
Measured: 24 months
Incidence of adverse events.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2008
- Primary completionApr 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helio Tedesco Silva Junior
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
- Investigators
- Helio T. Silva Junior, PhD, Principal investigator, Nephrology Division, Hospital do Rim, Federal University of São Paulo, BrazilClaudia R. Felipe, PhD, Study chair, Nephrology Division, Hospital do Rim, Federal University of São Paulo, BrazilValter D. Garcia, PhD, Study chair, Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, BrazilElias D. Neto, PhD, Study chair, Renal Transplant Service, Hospital das Clínicas, University of São Paulo School of Medicine, São Paulo, BrazilMario A. Filho, PhD, Study chair, Instituto de Urologia e Nefrologia & Medical School-FAMERP/HB-FUNFARME, São José do Rio Preto-SP, BrazilFabiana LC Cortieri, PhD, Study chair, Hospital University Evangélico de Curitiba, Curitiba, Parana, BrazilDeise BM Carvalho, PhD, Study chair, Nephrology Service, Bonsucesso General Hospital. Rio de Janeiro, BrazilJose OM Pestana, PhD, Study director, Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802268
- Sponsor's protocol ID
- 0468E8-3328
- Status last verified
- Feb 2013
- First submitted
- 22 Feb 2013
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT01802268
- Acronym / sponsor ID
- 0468E8-3328
- Conditions
- Kidney Transplant
- Keywords
- sirolimus, tacrolimus, early conversion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Helio Tedesco Silva JuniorUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Mar 2013 (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.
Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.
This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus | Active comparator | Drug: Conversion from Tacrolimus to SirolimusConversion from Tacrolimus to Sirolimus |
| Tacrolimus | Active comparator | Drug: Maintenance on tacrolimusMaintenance on tacrolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients older than 18 years,
- recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,
- patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,
- all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.
Key exclusion criteria (4 listed)
- patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,
- patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,
- patients with previous history of malignancy,
- patients with significant hematological or metabolic laboratorial abnormalities.
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 |
|---|---|---|
| Conversion from Tacrolimus to Sirolimus | Drug | Sirolimus |
| Maintenance on tacrolimus | Drug | Tacrolimus |
Primary outcome
Renal Function calculated using the 4 variable MDRD formula
Time frame: 24 months
6 secondary outcomes
Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.
Time frame: 24 months
Incidence of all treated acute rejections.
Time frame: 24 months
Incidence and severity of all tBCAR.
Time frame: 24 months
Patient and graft survival.
Time frame: 24 months
Incidence of treatment discontinuation
Time frame: 24 months
Incidence of adverse events.
Time frame: 24 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 1 Mar 2013.
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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.
Helio T. Silva Junior, PhD principal investigator
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Claudia R. Felipe, PhD study chair
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Valter D. Garcia, PhD study chair
Kidney & Pancreas Transplant Unit, Santa Casa de Misericordia, Porto Alegre, Brazil
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conversion from Tacrolimus to Sirolimus and Maintenance on tacrolimus in people with Kidney Transplant, run by Helio Tedesco Silva Junior at 6 sites 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 4 inclusion and 4 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 1 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Renal Function calculated using the 4 variable MDRD formula (time frame: 24 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 1 Mar 2013.