De Novo Renal TransplantationPhase 3NCT00464399
Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant Patients
A Phase 3 study testing everolimus in people with De Novo Renal Transplantation, run by Novartis Pharmaceuticals at 1 site in Norway.
Trial summary
To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- De Novo Renal Transplantation
- What is being tested?
- everolimus
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2006to Dec 2012
- Phase
- Phase 3
- 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
- Adult, Older adult
Who may be able to join
- Male or female aged above 18 years.
- Patients having received their first or second single renal transplant from deceased or living donor
- Patient willing and capable of giving written informed consent for study participation
- Patients treated with as induction therapy at the time of transplantation
- Patients maintained on a triple immunosuppressive regime consisting of cyclosporine (C-0 h between 100-250 ng/ml or a C-2 h between 900-1100 ng/ml), Enteric coated mycophenolate sodium (EC-MPS), minimum dose 1080 mg and corticosteroids, minimum dose 10 mg
- Patients without any biopsy proven acute rejection episode or treatment for any acute rejection since the transplant
- Females capable of becoming pregnant must have a negative pregnancy test prior to the switch to everolimus and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.
Who cannot join
- Recipient of multi-organ transplants, and or previously transplanted with any other organ different from a kidney transplant
- Patients with antibodies towards the donor kidney above 30%
- Patients receiving a renal transplant from HLA-identical sibling
- Presence of hyper sensitivity to drugs similar to everolimus ( e.g. macrolides)
- Patient with past (within the last two years) or present malignancy other than excised basal cell or squamous cell carcinoma of the skin
- Patients who are recipients of AB0 incompatible transplants
Show all 14Show fewer
- Patients with unsuitable laboratory values
- Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
- Patient with a current severe major local or systemic infection
- Patients requiring dialysis and/or having a calculated glomerular filtration rate (Cockcroft-Gault) < 20 ml/min
- Presence of intractable immunosuppressant complications or side effects (e.g., severe gastrointestinal adverse events) at the time of the switch
- Patients who are HIV positive or Hepatitis B surface antigen positive or Hepatitis C virus positive. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
- Evidence of severe liver disease
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant
To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events.
- Conditions
- De Novo Renal Transplantation
- Being tested
- everolimus
- Keywords
- De novo renal transplantation, CNI-free protocol, adults, everolimus, rejections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy proven acute rejections or treatment for acute rejections from the time of the conversion from cyclosporine based regimen to a cyclosporine free treatment with everolimus 7 weeks ± 7 days after transplantation until completion of 7 weeks after
Secondary outcomes (3)
Efficacy assessed by graft and patients survival from the time of conversion 7 weeks ± 7 days until the end of follow-up 12 months after transplantation
Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
Safety assessed by blood sampling for Hemoglobin, white blood cells (WBC), platelets, s-creatinine, ASAT, ALAT, ALP bilirubin, S-Na, S-K, S-Ca, S-P. S-Urea, S-creatin phosphokinase (S-CPK), u-alb/creatinine ratio
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startSep 2006
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for De Novo Renal 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464399
- Sponsor's protocol ID
- CRAD001ANO01
- Status last verified
- Nov 2016
- First submitted
- 19 Apr 2007
- Last updated
- 16 Nov 2016
- Results posted
- No
Publications
Holdaas H, Bentdal O, Pfeffer P, Mjornstedt L, Solbu D, Midtvedt K. Early, abrupt conversion of de novo renal transplant patients from cyclosporine to everolimus: results of a pilot study. Clin Transplant. 2008 May-Jun;22(3):366-71. doi: 10.1111/j.1399-0012.2008.00795.x. Epub 2008 Feb 12.
PubMed 18279419
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Feasibility and Safety of Early Switch to Everolimus From Cyclosporine in de Novo Renal Transplant
- ClinicalTrials.gov ID
- NCT00464399
- Acronym / sponsor ID
- CRAD001ANO01
- Conditions
- De Novo Renal Transplantation
- Keywords
- De novo renal transplantation, CNI-free protocol, adults, everolimus, rejections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2012 (actual)
- First posted
- 23 Apr 2007 (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.
To evaluate the safety and tolerability of early switch to everolimus from cyclosporine A in de novo renal transplant recipients by assessing rejection rate everolimus trough levels, other safety laboratory variables and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged above 18 years.
- Patients having received their first or second single renal transplant from deceased or living donor
- Patient willing and capable of giving written informed consent for study participation
- Patients treated with as induction therapy at the time of transplantation
- Patients maintained on a triple immunosuppressive regime consisting of cyclosporine (C-0 h between 100-250 ng/ml or a C-2 h between 900-1100 ng/ml), Enteric coated mycophenolate sodium (EC-MPS), minimum dose 1080 mg and corticosteroids, minimum dose 10 mg
Key exclusion criteria (14 listed)
- Recipient of multi-organ transplants, and or previously transplanted with any other organ different from a kidney transplant
- Patients with antibodies towards the donor kidney above 30%
- Patients receiving a renal transplant from HLA-identical sibling
- Presence of hyper sensitivity to drugs similar to everolimus ( e.g. macrolides)
- Patient with past (within the last two years) or present malignancy other than excised basal cell or squamous cell carcinoma of the skin
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 | Drug | – |
Primary outcome
Biopsy proven acute rejections or treatment for acute rejections from the time of the conversion from cyclosporine based regimen to a cyclosporine free treatment with everolimus 7 weeks ± 7 days after transplantation until completion of 7 weeks after
3 secondary outcomes
Efficacy assessed by graft and patients survival from the time of conversion 7 weeks ± 7 days until the end of follow-up 12 months after transplantation
Pharmacokinetics assessed by blood samples for everolimus concentration , cyclosporine concentrations
Safety assessed by blood sampling for Hemoglobin, white blood cells (WBC), platelets, s-creatinine, ASAT, ALAT, ALP bilirubin, S-Na, S-K, S-Ca, S-P. S-Urea, S-creatin phosphokinase (S-CPK), u-alb/creatinine ratio
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 16 Nov 2016.
- Results publication: PubMed 18279419Holdaas H, Bentdal O, Pfeffer P, Mjornstedt L, Solbu D, Midtvedt K. Early, abrupt conversion of de novo renal transplant patients from cyclosporine to everolimus: results of a pilot study. Clin Transplant. 2008 May-Jun;22(3):366-71. doi: 10.1111/j.1399-0012.2008.00795.x. Epub 2008 Feb 12.
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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 study director
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing everolimus in people with De Novo Renal Transplantation, run by Novartis Pharmaceuticals at 1 site in Norway.
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 7 inclusion and 14 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 16 Nov 2016. 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 Norway. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Biopsy proven acute rejections or treatment for acute rejections from the time of the conversion from cyclosporine based regimen to a cyclosporine free treatment with everolimus 7 weeks ± 7 days after transplantation until completion of 7 weeks after. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00464399, which also lists 1 linked publication.
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 16 Nov 2016.