|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
19 April 2022 |
|
Main ID: |
EUCTR2004-002310-10-ES |
|
Date of registration:
|
10/11/2004 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study to Investigate Cinacalcet Treatment in Haemodialysis Patients with Secondary Hyperparathyroidism - SENSOR
|
|
Scientific title:
|
Study to Investigate Cinacalcet Treatment in Haemodialysis Patients with Secondary Hyperparathyroidism - SENSOR |
|
Date of first enrolment:
|
17/11/2004 |
|
Target sample size:
|
800 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002310-10 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
- CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment
- Males or females = 18 years of age at the time of informed consent.
- Men and women participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test (or definitive evidence to demonstrate lack of pregnancy) within 30 days before randomisation, unless there is a definite history of amenorrhoea.
- An iPTH determination within 14 days before randomisation must be = 300 pg/mL (biPTH = 150 pg/mL).
- A serum calcium determination (corrected for calcium) within 14 days before randomisation must be = 8.4 mg/dL [2.1 mmol/L].
- Signed the Independent Ethics Committee (IEC) approved Informed Consent document, before any study specific procedures are initiated
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator.
- Are currently breast-feeding.
- Are performing peritoneal dialysis
- Have had a parathyroidectomy in the 3 months before day 1.
- Are currently enrolled in, or have not yet completed at least 30 days before day 1 other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable).
- Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets.
- Have a disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
|
Secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis
|
|
Intervention(s)
|
Product Name: Cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Cinacalcet
CAS Number: 364782-34-3
Current Sponsor code: AMG 073
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Product Name: Cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Cinacalcet
CAS Number: 364782-34-3
Current Sponsor code: AMG 073
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Product Name: Cinacalcet
Product Code: AMG 073
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Cinacalcet
CAS Number: 364782-34-3
Current Sponsor code: AMG 073
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
|
|
Primary Outcome(s)
|
Secondary Objective: To evaluate the safety of cinacalcet when co-administered with the first major meal after dialysis.
To evaluate a predefined strategy to manage nausea/vomiting during the study
|
|
Main Objective: To demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit.
|
|
Primary end point(s): The proportion of subjects with a mean iPTH £ 300 pg/mL at weeks 11 and 13
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 15/11/2004
Contact:
|
|