Kidney TransplantationPhase 4HERMESNCT01269684
Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients
A Phase 4 study testing Everolimus in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients. Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2008to Aug 2008
- 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
- Primary or secondary renal transplantation in the past 12-36 months.
- Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids.
- Moderately impaired renal function
Who cannot join
- Multi-organ recipients or previous transplantation with an organ other than a kidney.
- Acute rejection episodes in the last 6 months.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6-Month Open Pilot Study to Investigate the Safety and Tolerability of Immediate Conversion From Calcineurin Inhibitor Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients
The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.
Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.
- Conditions
- Kidney Transplantation
- Being tested
- Everolimus
- Keywords
- Kidney, renal, transplantation, tacrolimus, everolimus, stable allograft recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican
Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Routine safety laboratory
Measured: At baseline
Routine safety laboratory
Measured: Week 1
Routine safety laboratory
Measured: Month 1
Routine safety laboratory
Measured: Week 2
Routine safety laboratory
Measured: Week 3
Routine safety laboratory
Measured: Month 2
Routine safety laboratory
Measured: Month 4
Routine safety laboratory
Measured: Month 6
Secondary outcomes (3)
renal function
Measured: At baseline
renal function
Measured: Weeks 1, 2 and 3
renal function
Measured: Months 1, 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startAug 2008
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: No patient has never been included in the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269684
- Sponsor's protocol ID
- CRAD001ACH04
- Acronym
- HERMES
- Status last verified
- Feb 2017
- First submitted
- 5 Oct 2010
- Last updated
- 24 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month Open Pilot Study to Investigate the Safety and Tolerability of Immediate Conversion From Calcineurin Inhibitor Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT01269684
- Acronym / sponsor ID
- HERMES / CRAD001ACH04
- Conditions
- Kidney Transplantation
- Keywords
- Kidney, renal, transplantation, tacrolimus, everolimus, stable allograft recipients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient has never been included in the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Jan 2011 (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 investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.
Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EverolimusInitial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary or secondary renal transplantation in the past 12-36 months.
- Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids.
- Moderately impaired renal function
Key exclusion criteria (3 listed)
- Multi-organ recipients or previous transplantation with an organ other than a kidney.
- Acute rejection episodes in the last 6 months.
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| EverolimusAlso: CerticanInitial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml | Drug | 1 |
Primary outcome
Routine safety laboratory
Time frame: At baseline
Routine safety laboratory
Time frame: Week 1
Routine safety laboratory
Time frame: Month 1
Routine safety laboratory
Time frame: Week 2
Routine safety laboratory
Time frame: Week 3
Routine safety laboratory
Time frame: Month 2
Routine safety laboratory
Time frame: Month 4
Routine safety laboratory
Time frame: Month 6
3 secondary outcomes
renal function
Time frame: At baseline
renal function
Time frame: Weeks 1, 2 and 3
renal function
Time frame: Months 1, 2, 4 and 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Everolimus in people with Kidney Transplantation, run by Novartis Pharmaceuticals at 1 site in Switzerland.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Feb 2017. 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 Switzerland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Routine safety laboratory (time frame: At baseline). The study lists 8 primary outcomes in all. 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 24 Feb 2017.