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 - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-001787-23-IT
• Date of registration: 10/10/2008
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• 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 - ND
• 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 - ND
• Date of first enrolment: 23/07/2008
• 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: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Patients must give written informed consent before any assessment is performed. 2. Men or women of at least 18 years old. 3. Patient must be treated with a stable maintenance hemodialysis (i.e. no change in dialysis material and parameters) 3 times per week for > 3 months before screening and planned to be maintained the same throughout the study duration. 4. Patient must be on restricted phosphate diet at screening and throughout the study. 5. Patient has a controlled serum phosphate > 3.0 mg/dL (> 0.97 mmol/L) and < 6.0 mg/dL (< 1.9 mmol/L), as indicated by the average of the 2 latest pre-dialysis laboratory values reported prior to screening, if currently under phosphate binder therapy. 6. Patient has a serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L), obtained from central laboratory, prior to study treatment initiation. 7. Patient must have a Urea Reduction Ratio of > 65% (obtained within 2 weeks prior to screening). 8. If patient has a history of parathyroidectomy, iPTH and calcium-phosphate product levels should be stable within 30 days prior to screening. 9. Patient must be on a stable phosphate binder dose (i.e. No change in prescribed dose) for at least 30 days prior to screening, or is newly diagnosed with hyperphosphatemia and has not initiated treatment with phosphate binder yet. 10. Patient must, in the investigator?s opinion, be compliant with prescribed phosphate binders. 11. If patient is currently being treated with calcimimetics, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the total core study duration. 12. 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. 13. If patient is currently being treated with IV iron, the prescribed dose must be constant for at least 30 days prior to screening and should remain constant during the total core study duration. 14. If patient is currently being treated for osteoporosis, the prescribed dose must be constant for at least 30 days prior to screening and 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:
1. Patient is on peritoneal dialysis or a non-conventional hemodialysis technique (e.g. hemofiltration, hemodiafiltration) 2. Patient has a parathyroidectomy or transplant scheduled during the study. 3. Patient has an uncontrolled hyperparathyroidism (i.e. intact PTH > 800 pg/mL within 30 days prior to study screening) 4. Patient has a history of hemochromatosis or ferritin > 800 μg/L. 5. Patient has a clinically significant GI disorder (i.e. swallowing disorder, active dysphagia, bowel obstruction, severe GI motility disorder) 6. Patient has a chronic unstable GI disorder (e.g. Irritable Bowel Syndrome, Inflammatory Bowel Disease, chronic abdominal pain, chronic diarrhea)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
MedDRA version: 9.1 Level: LLT Classification code 10020711 Term: Hyperphosphataemia

Intervention(s)

Product Name: SBR759
Product Code: SBR759
Pharmaceutical Form: Powder for oral solution
Current Sponsor code: SBR759
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: RENAGEL
Pharmaceutical Form: Tablet
INN or Proposed INN: Sevelamer
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-

Primary Outcome(s)

Main Objective: To demonstrate superior efficacy or at least non-inferiority of SBR759 compared to sevelamer HCl, as 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): To demonstrate superior efficacy or at least non-inferiority of SBR759 compared to sevelamer HCl, as 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.

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. PLS SEE PROTOCOL

Secondary ID(s)

CSBR759A2201

2006-001787-23-FR