|
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:
|
27 July 2020 |
|
Main ID: |
EUCTR2006-001787-23-GB |
|
Date of registration:
|
18/06/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A 12-week, open label, multicenter, titration study, with a 9-
month maintenance treatment extension, to demonstrate
efficacy of SBR759 compared to sevelamer HCl in lowering
serum phosphate levels in Chronic Kidney Disease
patients on hemodialysis
|
|
Scientific title:
|
A 12-week, open label, multicenter, titration study, with a 9-
month maintenance treatment extension, to demonstrate
efficacy of SBR759 compared to sevelamer HCl in lowering
serum phosphate levels in Chronic Kidney Disease
patients on hemodialysis |
|
Date of first enrolment:
|
17/12/2008 |
|
Target sample size:
|
378 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001787-23 |
|
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: yes
Other trial design description: Stratified per serum phosphorus levels (= to 75.mg/dL)
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
Belgium
|
Estonia
|
Finland
|
France
|
Germany
|
Italy
|
Latvia
|
Lithuania
|
|
Spain
|
Sweden
|
United Kingdom
| | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
- Men or women of at least 18 years old.
- Patient must be on maintenance renal replacement therapy (i.e. hemodialysis, hemofiltration or hemodiafiltration) 3 times per week for > 3 months before screening with a stable dialysis prescription, as defined by no change in material (i.e. dialyzer, filter/membrane) type and dialysis duration for = 4 weeks before screening and planned to be maintained the same throughout the study duration.
- Patient must be on restricted phosphate diet at screening and throughout the study.
- If currently under phosphate binder therapy, patient has a controlled serum phosphate > 3.0 mg/dL (> 0.97 mmol/L) and =6.5 mg/dL ( =2.1 mmol/L) as indicated
by the single value obtained from the central laboratory at screening (i.e. obtained at a 72-hr postdialysis interval)
- Patient has a serum phosphate level =6.0 mg/dL ( =1.9 mmol/L) obtained at a
72-hr post-dialysis interval, from central laboratory, prior to randomization and study
treatment initiation (i.e. after 2 weeks washout if no exception is applicable
- Patient must have a Urea Reduction Ratio of = 60% (obtained from central laboratory at screening).
- Patient must be on a stable phosphate binder dose (i.e. No change in prescribed dose) or not have received phosphate binder therapy for at least 4 weeks prior to
screening.
- Patient must, in the investigator’s opinion, be compliant with prescribed phosphate
binders.
- If patient is currently being treated with calcimimetics, the prescribed dose must be
constant for at least 30 days prior to baseline and should remain constant during the total core study duration.
- If patient is currently being treated with vitamin D, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the total core study duration.
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:
?? Patient is on peritoneal dialysis.
?? Patient has a parathyroidectomy within 3 months prior to screening or transplant scheduled during the study.
?? Patient has an uncontrolled hyperparathyroidism (i.e. intact PTH > 800pg/ml obtained from the central laboratory at screening).
?? Patient has a history of hemochromatosis or ferritin > 1000 µg/L obtained from the central laboratory at screening.
?? Patient has a clinically significant GI disorder
?? Patient has a chronic unstable GI disorder
?? Patient has an history of major gastrointestinal tract surgery
- Patient has a clinically significant unstable medical condition as per investigator judgement.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Patient is known to currently have a drug or alcohol abuse problem.
- Patient has a known history of immunodeficiency disease, e.g. existing positive HIV
(ELISA or Western blot) test result.
- History of intolerance to sevelamer HCl.
- Patient is currently being treated with oral iron.
- Patient currently has an active antiviral treatment for Hepatitis B and/or C (within 30 days prior to screening).
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant. UNLESS they are using a highly effective method of birth control
(i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some
intrauterine devices (IUDs).
- Patient is treated with osteoporosis treatment within 30 days prior to screening
- Patient has a transferrin saturation > 60%, obtained from central lab, at screening
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Hyperphosphataemia in patients with Chronic Kidney Disease (CKD) on hemodialysis
MedDRA version: 9.1
Level: LLT
Classification code 10020712
Term: Hyperphosphatemia
|
|
Intervention(s)
|
Product Name: SBR759 1000mg
Product Code: SBR759
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: not yet established
Current Sponsor code: SBR759-NXA 001
Other descriptive name: Fe(OH)+ Starch + saccharose complex
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-
Trade Name: Renagel 800mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sevelamer hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800mg-
Product Name: SBR759 1500mg
Product Code: SBR759
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: not yet established
Current Sponsor code: SBR759-NXA 001
Other descriptive name: Fe(OH)+ Starch + saccharose complex
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1500-
Product Name: SBR759 3000mg
Product Code: SBR759
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: not yet established
Current Sponsor code: SBR759-NXA 001
Other descriptive name: Fe(OH)+ Starch + saccharose complex
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3000-
|
|
Primary Outcome(s)
|
Secondary Objective: To evaluate safety and tolerability of SBR759 compared to sevelamer HCl over a 12-week period.
To evaluate whether SBR759 has superior efficacy at week 12 compared to sevelamer HCl, as measured by the number of patients with a serum calcium-phosphate product levels below or equal to 55 mg2/dL2.
To evaluate whether SBR759 is associated with less increase in serum iPTH levels compared to sevelamer HCl at 12 weeks.
To evaluate whether SBR759 has an equivalent rate of hypercalcemia events at 12 weeks compared to sevelamer HCl as measured by serum calcium levels.
To evaluate changes in patient-reported gastrointestinal symptom burden, using
gastrointestinal symptom rating scale (GSRS) total and subscales scores, in patients treated with SBR759 compared to patients treated with sevelamer HCl.
|
Main Objective: This study is designed to demonstrate superior or at least non-inferior
efficacy of SBR759 in phoshate binding, versus sevelamer HCl and evaluate safety over a long term exposure. Efficacy will be measured by the number of patients with a serum phosphate level below or equal to 5.5 mg/dl (i.e. 1.78 mmol/L) at 12 weeks
|
|
Primary end point(s): Number of patients with a serum phosphate level below or equal to 5.5 mg/dL (1.78 mmol/L)
|
|
Secondary ID(s)
|
|
CSBR759A2201
|
|
2006-001787-23-FR
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 17/12/2008
Contact:
|
|