Disorder Related to Renal TransplantationPhase 4NCT02683291
Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients
A Phase 4 study testing sirolimus, tacrolimus and mycophenolate in people with Disorder Related to Renal Transplantation and Cytomegalovirus Infections, run by Associação Médico Espírita de Botucatu.
Trial summary
There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Disorder Related to Renal Transplantation, Cytomegalovirus Infections
- What is being tested?
- sirolimus, tacrolimus and mycophenolate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients aged more than 60 years and recipients of compatible renal transplant
Who cannot join
- Receptors of multiple organs;
- non-heart beating donors;
- donors aged under 5 or over 65 years;
- Patients with body mass index greater than 35
About this study
Official title: Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial
There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.
Read the detailed description
Study Design
This will be a single-center, prospective, 12-month randomized controlled trial aiming to compare sirolimus associated with tacrolimus in elderly renal transplant patients as to safety and incidence of cytomegalovirus (CMV) infection.
Treatments
In the control group (Tacrolimus + Mycophenolate) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug.
In the treatment group (Tacrolimus + sirolimus) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period).
In all groups, patients will receive prednisone 30 mg/day (in the first month with weekly reductions up to 5 mg/day at the end of the second month). Induction therapy consisted of basiliximab or antithymocyte globulin (Thymoglobulin, Genzyme®). Thymoglobulin will be used in patients with panel reactivity class I greater than 50 % (at a dose of 1mg/kg for 5 days).
- Being tested
- sirolimus, tacrolimus, mycophenolate, Prednisone, Basiliximab
- Keywords
- Kidney transplantation, sirolimus, cytomegalovirus, aged
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sirolimusDrug
Also called Rapamycin, Rapamune
tacrolimusDrug
Also called Prograf, FK506
mycophenolateDrug
Also called Myfortic, Mycophenolate Sodium
PrednisoneDrug
Also called Meticorten
Prednisone 30mg/day
BasiliximabDrug
Also called Simulect
Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
ThymoglobulinDrug
Also called antithymocyte globulin
Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus + Mycophenolate | Active comparator | The investigators wil be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug.
Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 % Receives: Drug: tacrolimus; Drug: mycophenolate; Drug: Prednisone; Drug: Basiliximab; Drug: Thymoglobulin |
| Tacrolimus + Sirolimus | Experimental | The investigators will be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period).
Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 % Receives: Drug: sirolimus; Drug: tacrolimus; Drug: Prednisone; Drug: Basiliximab; Drug: Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated glomerular filtration rate from baseline
The primary end-point will be evaluated the estimated glomerular filtration rate (eGFR) over 12 months of renal transplantation. The investigators will be measure the change in eGFR during 12 month follow-up. Glomerular filtration rate will be estimated by the MDRD equation (Modification of Diet in Renal Disease).
Measured: Baseline, 1 month, 3 months, 6 months and 12 months
Secondary outcomes (1)
Incidence of cytomegalovirus Infection (CMV)
The secondary end-point will be evaluated the incidence of cytomegalovirus (CMV) infection. CMV infection will be defined based on detection of CMV viral replication (CMV pp65 antigenemia more than zero) in asymptomatic patients. CMV disease will be defined based on the evidence of CMV infection with related symptoms. For the positive cases treatment will be carried out with ganciclovir 5 mg/kg/day twice daily adjusted for renal function for a minimum of 14 days.
Measured: Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação Médico Espírita de Botucatu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Gustavo Modelli de Andrade, Associação Médico Espírita de Botucatu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683291
- Sponsor's protocol ID
- 16966913.6.0000.5411
- Status last verified
- Feb 2016
- First submitted
- 5 Feb 2016
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02683291
- Acronym / sponsor ID
- 16966913.6.0000.5411
- Keywords
- Kidney transplantation, sirolimus, cytomegalovirus, aged
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Associação Médico Espírita de BotucatuUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Feb 2016 (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.
There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.
Detailed description
Study Design
This will be a single-center, prospective, 12-month randomized controlled trial aiming to compare sirolimus associated with tacrolimus in elderly renal transplant patients as to safety and incidence of cytomegalovirus (CMV) infection.
Treatments
In the control group (Tacrolimus + Mycophenolate) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug.
In the treatment group (Tacrolimus + sirolimus) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period).
In all groups, patients will receive prednisone 30 mg/day (in the first month with weekly reductions up to 5 mg/day at the end of the second month). Induction therapy consisted of basiliximab or antithymocyte globulin (Thymoglobulin, Genzyme®). Thymoglobulin will be used in patients with panel reactivity class I greater than 50 % (at a dose of 1mg/kg for 5 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus + Mycophenolate | Active comparator | Drug: tacrolimus, Drug: mycophenolate, Drug: Prednisone, Drug: Basiliximab, Drug: ThymoglobulinThe investigators wil be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug. Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 % |
| Tacrolimus + Sirolimus | Experimental | Drug: sirolimus, Drug: tacrolimus, Drug: Prednisone, Drug: Basiliximab, Drug: ThymoglobulinThe investigators will be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period). Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 % |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients aged more than 60 years and recipients of compatible renal transplant
Key exclusion criteria (4 listed)
- Receptors of multiple organs;
- non-heart beating donors;
- donors aged under 5 or over 65 years;
- Patients with body mass index greater than 35
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 |
|---|---|---|
| sirolimusAlso: Rapamycin, Rapamune | Drug | Tacrolimus + Sirolimus |
| tacrolimusAlso: Prograf, FK506 | Drug | Tacrolimus + Mycophenolate, Tacrolimus + Sirolimus |
| mycophenolateAlso: Myfortic, Mycophenolate Sodium | Drug | Tacrolimus + Mycophenolate |
| PrednisoneAlso: MeticortenPrednisone 30mg/day | Drug | Tacrolimus + Mycophenolate, Tacrolimus + Sirolimus |
| BasiliximabAlso: SimulectBasiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 % | Drug | Tacrolimus + Mycophenolate, Tacrolimus + Sirolimus |
| ThymoglobulinAlso: antithymocyte globulinThymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 % | Drug | Tacrolimus + Mycophenolate, Tacrolimus + Sirolimus |
Primary outcome
Change in estimated glomerular filtration rate from baseline
Time frame: Baseline, 1 month, 3 months, 6 months and 12 months
The primary end-point will be evaluated the estimated glomerular filtration rate (eGFR) over 12 months of renal transplantation. The investigators will be measure the change in eGFR during 12 month follow-up. Glomerular filtration rate will be estimated by the MDRD equation (Modification of Diet in Renal Disease).
1 secondary outcome
Incidence of cytomegalovirus Infection (CMV)
Time frame: Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 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 17 Feb 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sirolimus, tacrolimus and mycophenolate in people with Disorder Related to Renal Transplantation and Cytomegalovirus Infections, run by Associação Médico Espírita de Botucatu.
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 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in estimated glomerular filtration rate from baseline (time frame: Baseline, 1 month, 3 months, 6 months and 12 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 17 Feb 2016.