Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000320055
Ethics application status
Approved
Date submitted
1/09/2009
Date registered
20/04/2010
Date last updated
20/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Removal Of Cyclosporine With Everolimus On Inflammation And Vascular Endpoints
Scientific title
A prospective, open label, controlled, multicentre trial to assess the effect of an induction regimen of Neoral (Registered Trademark), Myfortic (Registered Trademark) and corticosteroids, followed by administration of Certican (Registered Trademark) together with withdrawal of
Neoral (Registered Trademark) on inflammatory and cardiovascular markers in kidney transplant recipients
Secondary ID [1] 251628 0
None
Universal Trial Number (UTN)
Trial acronym
REVIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular risk 243615 0
Condition category
Condition code
Renal and Urogenital 239910 239910 0 0
Kidney disease
Cardiovascular 239911 239911 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 239912 239912 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Everolimus - available in 0.25mg, 0.5mg and 0.75mg tablets. Typical dose amount is 1.5mg orally twice daily and adjusted to keep target therapeutic levels as specified in protocol. Duration of up to 18 months post-kidney transplant.
Intervention code [1] 241203 0
Treatment: Drugs
Intervention code [2] 241204 0
Prevention
Comparator / control treatment
Cyclosporine - available in 10mg, 25mg, 50mg and 100mg tablets. Typical dose amount is 5mg/kg orally taken twice daily and adjusted to keep target therapeutic levels as specified in protocol. Duration of up to 18 months post-kidney transplant.
Control group
Active

Outcomes
Primary outcome [1] 240695 0
Vascular function determined by pulse wave velocity and aortic augmentation index using SphymaCor system (Registered Trademark)
Timepoint [1] 240695 0
3, 6, 12 and 18 months post-transplant
Secondary outcome [1] 257337 0
Metabolic:

Blood analysis (serum/plasma) for glucose, lipids, C-reactive protein (CRP) and pro-inflammatory cytokines

Sphygmomanometer for measurement of blood pressure
Timepoint [1] 257337 0
3, 6, 12 and 18 months post-transplant
Secondary outcome [2] 257338 0
Proteinuria by urine analysis (immunoassay)
Timepoint [2] 257338 0
3, 6, 12 and 18 months post-transplant
Secondary outcome [3] 257339 0
Cardiac function determined by echocardiography
Timepoint [3] 257339 0
3 and 18 months post-transplant
Secondary outcome [4] 257340 0
Glomerular filtration rate
Timepoint [4] 257340 0
3, 6, 12 and 18 months post-transplant
Secondary outcome [5] 257341 0
Cardiovascular outcomes:
1) History for details of hospitalisations for cardiovascular-related events (using medical records)
2) Blood analysis for cholesterol level
Timepoint [5] 257341 0
3, 6, 12 and 18 months post-transplant
Secondary outcome [6] 257342 0
Transplant outcomes (rejection, graft and patient survival)
Timepoint [6] 257342 0
3, 6, 12 and 18 months post-transplant
Secondary outcome [7] 257343 0
Kidney allograft biopsy (to look for evidence of rejection, scarring, drug toxicity)
Timepoint [7] 257343 0
3 and 18 months post-kidney transplant

Eligibility
Key inclusion criteria
1. Males and females aged 18-65 years inclusive.
2. Recipients of cadaveric, living unrelated or living related donor kidney transplants.
3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at screening, and are required to practice a medically accepted effective method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are recipients of multiple organ transplants, kidney and pancreas, or previous transplant with any organ other than kidney but excluding recipients receiving two kidneys from the same donor.
2. Patients receiving tumour-resected kidneys, kidneys from non-heart beating donors or deceased donor >65 years and/or with terminal creatinine (of deceased-donor) of =150micromol/Litre (umol/L).
3. Patients at high immunological risk of graft loss, indicated by peak panel reactive antibody (PRA) >50% or loss of a previous renal allograft within the first 6 months of transplantation due to acute rejection.
4. Presence of any severe allergy or hypersensitivity to drugs similar to Certican (Registered Trademark) (e.g. macrolides) or Neoral (Registered Trademark).
5. Patients who are recipients of A-B-O blood group incompatible transplants or complement-dependent cytotoxicity (CDC) T or B cell cross-match positive transplants. Patients with documented donor-specific antibodies are not excluded if allogeneic complement-dependent cytotoxicity (CDC) cross-match pre-transplant is negative.
6. Patients who are known to have chronic active Hepatitis C, or who are human immunodeficiency virus (HIV) or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to randomization are acceptable. Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C are excluded.
7. Body mass index (BMI) >35kg/m2.
8. Patients with symptoms of significant somatic or mental illness, or inability to co-operate or communicate with the investigator.
9. Unresolved history of drug or alcohol abuse.
10. Patients with clinically significant infections requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study.
11. Patients with a history of malignancy (other than excised basal cell carcinoma of the skin).
12. Breastfeeding women.
13. Abnormal physical or laboratory findings of clinical significance, which at investigator discretion would interfere with the objectives of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237561 0
Commercial sector/Industry
Name [1] 237561 0
Novartis Pharmaceutical Company Pty Ltd
Country [1] 237561 0
Australia
Funding source category [2] 237562 0
Commercial sector/Industry
Name [2] 237562 0
Novartis Pharmaceutical Company Pty Ltd
Country [2] 237562 0
Australia
Primary sponsor type
Government body
Name
Heath Department of Western Australia
Address
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 237038 0
Hospital
Name [1] 237038 0
Sir Charles Gairdner Hospital
Address [1] 237038 0
Hospital Avenue
Nedlands
Western Australia 6009
Country [1] 237038 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243693 0
Sir Charles Gairdner Group Human Research Ethics Committee
Ethics committee address [1] 243693 0
Ethics committee country [1] 243693 0
Australia
Date submitted for ethics approval [1] 243693 0
Approval date [1] 243693 0
Ethics approval number [1] 243693 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30104 0
Address 30104 0
Country 30104 0
Phone 30104 0
Fax 30104 0
Email 30104 0
Contact person for public queries
Name 13351 0
Wai Lim
Address 13351 0
Sir Charles Gairdner Hospital
Department of Renal Medicine
Hospital Avenue
NEDLANDS Western Australia 6009
Country 13351 0
Australia
Phone 13351 0
+61 8 9346 2799
Fax 13351 0
Email 13351 0
[email protected]
Contact person for scientific queries
Name 4279 0
Wai Lim
Address 4279 0
Sir Charles Gairdner Hospital
Department of Renal Medicine
Hospital Avenue
NEDLANDS Western Australia 6009
Country 4279 0
Australia
Phone 4279 0
+61 8 9346 2799
Fax 4279 0
Email 4279 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of early conversion from cyclosporin to everolimus on left ventricular mass index: A randomized controlled trial.2017https://dx.doi.org/10.1111/ctr.13043
N.B. These documents automatically identified may not have been verified by the study sponsor.