Kidney DiseasesPhase 2NCT00325325
Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus
A Phase 2 study testing everolimus and tacrolimus in people with Kidney Diseases, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- everolimus and tacrolimus
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Jun 2007
- Phase
- Phase 2
- 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
- Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft
Who cannot join
- Non-functioning kidneys
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Ramón y Cajal
Madrid, 28034
Julio Pascual, MD
About this study
Official title: A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation
The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.
Read the detailed description
To address the pharmacokinetic profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation. Patients will receive triple therapy steroids, tacrolimus and everolimus. Tacrolimus will be administered at a dose of 0.15 mg/kg/day to achieve 10-15 ng/ml 14 days, and 5-10 thereafter. During the first 6 weeks (the PK study period) everolimus will be assigned to fixed dose of 0.75 or 1.5 mg bid. After day 42, everolimus will be adjusted for 3-8 ng/ml and tacrolimus minimized to optimize graft function. Efficacy and safety parameters at 6 months post-transplantation will be secondary endpoints.
- Conditions
- Kidney Diseases
- Being tested
- everolimus and tacrolimus
- Keywords
- Kidney Transplantation
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimus and tacrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startJan 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Astellas Pharma Inc
- Investigators
- Julio Pascual, MD, Study chair, Hospital Universitario Ramon y CajalGorka G Erauzquin, MD, Principal investigator, Hospital de Cruces, BilbaoJosé M Morales, MD, Principal investigator, Hospital 12 de Octubre, MadridLuis Pallardó, MD, Principal investigator, Hospital Dr Peset, ValenciaRicardo Lauzurica, MD, Principal investigator, Hospital Germans, Trias i Puyol, BadalonaDomingo del Castillo, MD, Principal investigator, Hospital Reina Sofía, CórdobaJosep M Grinyó, MD, Principal investigator, Hospital de Bellvitge, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325325
- Sponsor's protocol ID
- EVEROTAC
- Status last verified
- May 2006
- First submitted
- 11 May 2006
- Last updated
- 26 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Pharmacokinetic Characteristics of Everolimus in Patients Treated With Tacrolimus-Based Immunosuppression in De Novo Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00325325
- Acronym / sponsor ID
- EVEROTAC
- Conditions
- Kidney Diseases
- Keywords
- Kidney Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Novartis, Astellas Pharma Inc
- Study start
- Jan 2006
- Study completion
- Jun 2007
- First posted
- 12 May 2006 (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.
The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.
Detailed description
To address the pharmacokinetic profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation. Patients will receive triple therapy steroids, tacrolimus and everolimus. Tacrolimus will be administered at a dose of 0.15 mg/kg/day to achieve 10-15 ng/ml 14 days, and 5-10 thereafter. During the first 6 weeks (the PK study period) everolimus will be assigned to fixed dose of 0.75 or 1.5 mg bid. After day 42, everolimus will be adjusted for 3-8 ng/ml and tacrolimus minimized to optimize graft function. Efficacy and safety parameters at 6 months post-transplantation will be secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney transplant recipients aged 18-65 years old with a presumed immediately functioning graft
Key exclusion criteria (1 listed)
- Non-functioning kidneys
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 |
|---|---|---|
| everolimus and tacrolimus | Drug | – |
Primary outcome
12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2006.
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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.
Julio Pascual, MD study chair
Hospital Universitario Ramon y Cajal
Gorka G Erauzquin, MD principal investigator
Hospital de Cruces, Bilbao
José M Morales, MD principal investigator
Hospital 12 de Octubre, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus and tacrolimus in people with Kidney Diseases, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 1 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 26 Oct 2006. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Julio Pascual, MD (+34 91 3368018, julpascual@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-hour PK profiles of everolimus and tacrolimus on day 14 post-transplantation with everolimus 1.5 mg versus 3 mg per day. 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 26 Oct 2006.