A Phase III, Randomised, Double-blind, Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)

• Conditions: Hyperphosphataemia; MedDRA version: 8.1Level: LLTClassification code 10020711Term: Hyperphosphataemia

• Registration Number: EUCTR2006-003323-37-HU
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-15
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. The subject is capable of reading and comprehending the informed consent and complying with study procedures and provides written informed consent.
2. The subject is male or female and 18 years of age or over.
3. The subject has a diagnosis of CKD (Stage V) as defined by the K/DOQI Guidelines and is on dialysis.
4. The subject is clinically stable on haemodialysis or peritoneal dialysis for at least 3 months, as judged by the Investigator.
5. The subject has stable phosphate control (as judged by the investigator) using phosphate-binding medication for at least 1 month prior to the screening visit.
6. The subject is on a stabilised phosphorus diet, as considered appropriate by the physician.
7. The subject is undergoing regular dialysis treatment:
- If the subject is on haemodialysis, this is scheduled 3 times per week in a hospital or centre setting. The duration must be between 3 to 5 hours or if high-flux dialysis a minimum of 2.5 hours, depending on the standard of care in each centre.
- If the subject is on peritoneal dialysis, this is either daily APD (Automated Peritoneal Dialysis) or CAPD (Continuous Ambulatory Peritoneal Dialysis), the latter employing at least 3 bag changes per day.
8. The subject has serum phosphorus level, as measured by the Central Laboratory, less than 2.42 mmol/L (7.5 mg/dL) at screening.
9. The subject has calcium dialysate content between 1 to 1.75 mmol/L (2 to 3.5 mEq/L), depending on the standard of care in each centre. Calcium dialysate content should remain constant for the duration of the study.
10. The subject has baseline Kt/V (single pool) of at least 1.2 for haemodialysis subjects, and a weekly Kt/V value of at least 1.8 for peritoneal dialysis subjects.
11. The subject, if female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant during the course of the clinical study.
12. Male subjects must agree to use appropriate contraception during the course of the clinical study.

Additional Criteria for Randomisation at Visit 5 (Baseline Visit):

13. At Visit 3 (Week-2) or Visit 4 (Week-1), the subject has a serum phosphorus level, as measured by the Central Laboratory = to 1.94 mmol/L (6.0 mg/dL), and is at least 15% greater than at screening.
OR
At Visit 2 (Week -3) the subject has a serum phosphorus level, as measured by the Central Laboratory = to 2.58 mmol/L (8.0 mg/dL) and is at least 15% greater than at screening.

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. The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
2. The subject has a serum albumin level <30.0 g/L.
3. The subject has a history of PTH levels consistently/frequently >1000 pg/mL.
4. The subject has a body mass index (BMI) =16.0 kg/m2 or =40.0 kg/m2.
5. The subject has currently or has a history of significant gastrointestinal (GI) motility problems, including dysphagia or swallowing difficulty, or GI abnormalities such as chronic or severe constipation, sigmoid colitis, ulcers, or major GI surgery.
6. The subject has biliary obstruction or proven liver dysfunction, i.e., cirrhosis, hepatorenal syndrome, or has liver function tests 3 times the normal values for at least 2 of the measurements (ALT, AST, alkaline phosphatase, and gamma-glutamyl-transferase).
7. The subject is known to have a positive test for HIV 1 and 2 antibodies.
8. The subject has a history of clinically significant severe lactose intolerance or sensitivity (the placebo tablets have a high lactose content), as judged by the investigator.
9. The subject has a history of substance or alcohol abuse within the last year.
10. The subject has seizure disorders.
11. The subject has a history of drug or other allergy that contraindicates their participation.
12. The subject is using any of the following drugs:
- over-the-counter products containing calcium, magnesium and aluminium, and/or nutritional supplements which can not be stopped during the study period
- colestyramine, colestipol or colesevelam
13. The subject has a temporary catheter as a vascular access and is showing active signs of inflammation or infection as a result of this.
14. The subject has participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days, prior to signing of the informed consent.
15. The subject has had prior to exposure to MCI-196 in the past 12 months.
16. If on peritoneal dialysis, the subject has a recent history of peritonitis (within the previous 3 months).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified