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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00098007




Registration number
NCT00098007
Ethics application status
Date submitted
1/12/2004
Date registered
2/12/2004
Date last updated
23/02/2017

Titles & IDs
Public title
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
Scientific title
Six-month, Multicenter, Randomized, Open-label Study of the Safety, Tolerability and Efficacy of Two Neoral Doses in Addition to Certican and Steroids in de Novo Heart Transplant Recipients
Secondary ID [1] 0 0
RAD/Certican
Secondary ID [2] 0 0
CRAD001A2403
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Everolimus (Certican)

Treatment: Drugs: Everolimus (Certican)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Renal function at 6 months post-transplant.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Incidence of biopsy proven acute rejection =3A at 6 months.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Incidence of acute rejection associated with hemodynamic compromise at 6 months.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Incidence of graft loss at 6 months.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Incidence of death at 6 months.
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Incidence of premature patient withdrawal and study treatment discontinuation at 6 months.
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
Inclusion criteria Male or female cardiac patients 18-65 years old undergoing primary heart
transplantation.

Females of potential childbearing age must have a negative serum pregnancy test within 7
days prior to enrollment. Effective contraception must be used during the trial and for 6
weeks following discontinuation of the study medication, even where there has been a
history of infertility.

Patients who are willing and able to participate in the full course of the study and for
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
Exclusion criteria Patients with donor hearts greater than 60 years of age and/or with a
cold ischemia time of more than 6 hours and/or donor hearts which have obvious coronary
disease or are known to have heart disease at time of transplant.

Patients who are recipients of multiple solid organ transplants, or who are previously
received transplanted organs.

Patients who had received any investigational drug or who have been treated with an
immunosuppressive drug treatment within 4 weeks prior to study entry.

Patients with serum creatinine level > 250 mol/L. Patients with platelet count = 50,000/mm3
or with a white blood cell count of = 2,500/mm3.

Patients with active systemic infection, according to the investigator judgment, requiring
continued therapy.

Patients with a known hypersensitivity to mTOR inhibitors. Patients with Panel Reactive
Antibodies = 25%. Presence of severe hypercholesterolemia (= 350mg/dL;=9 mmol/L) or
hypertriglyceridemia (= 750 mg/dL; = 8.5 mmol/L).

Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic
treatment, or hypersensitivity to drugs similar to Certican (e.g., macrolides).

Symptoms of a significant mental illness, which is in the opinion of the investigator may
interfere with the patients ability to comply with the protocol. History of drug or alcohol
abuse within 1 year of baseline.

Patients with any past (within the last 5 years) or present malignancy other than excised
squamous or basal cell carcinoma.

Patients with any history of significant coagulopathy or medical condition requiring
long-term anticoagulation after transplantation (low dose of aspirin treatment is allowed).

Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to
study entry which would interfere with the objectives of the study.

Inability to cooperate or communicate with the investigator. Female of childbearing
potential to who are planning to become pregnant, who are pregnant and/or lactating, who
are unwilling to use effective means of contraception.

Breast feeding women. Patients who are recipients of A-B-O incompatible transplants.
Patients who are known to have chronic active Hepatitis C (PCR+ only), who are 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 (PCR+ only) are excluded

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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/01/2007
Sample size
Target
Accrual to date
Final
199
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Chermside
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment postcode(s) [1] 0 0
4032 - Chermside
Recruitment postcode(s) [2] 0 0
NSW2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Austria
State/province [11] 0 0
Innsbruck
Country [12] 0 0
Austria
State/province [12] 0 0
Vienna
Country [13] 0 0
Brazil
State/province [13] 0 0
MG
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Germany
State/province [17] 0 0
Hannover
Country [18] 0 0
Germany
State/province [18] 0 0
Kiel
Country [19] 0 0
Italy
State/province [19] 0 0
MI
Country [20] 0 0
Italy
State/province [20] 0 0
Napoli
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Spain
State/province [22] 0 0
La Coruna
Country [23] 0 0
Spain
State/province [23] 0 0
Llobregat
Country [24] 0 0
Spain
State/province [24] 0 0
Oviedo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is designed to evaluate whether Neoral dose optimization together with a
therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the
pivotal cardiac trial while maintaining the efficacy.

This objective will be assessed by comparing renal function post-transplant between 2 groups
of patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00098007
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries