A phase 3 study to investigate long term safety and tolerability of PA21, a phosphate binder, in dialysis patients with hyperphospatemia

• Conditions: Control of hyperphosphataemia in patients with chronic kidney disease on dialysis; MedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857; MedDRA version: 14.1Level: LLTClassification code 10020712Term: HyperphosphatemiaSystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2010-022012-40-DE
• Lead Sponsor: Vifor (International) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-09
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Subjects who have completed treatment in Protocol PA-CL-05A (Stage 1
or Stage 2) (except subjects randomised to the PA21 low dose group of the
Stage 2 primary efficacy assessment).

2. Subjects (or their legally acceptable representative) who have provided the
appropriate written informed consent. Subjects must provide written
informed consent before any study-specific procedures are performed
including screening procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

1. Subjects randomised to the PA21 low dose group of the Stage 2 primary
efficacy assessment of Protocol PA-CL-05A.

2. Subjects with hypercalcaemia (total serum calcium >2.75 mmol/L or
>11.00 mg/dL at the previous study visit in Protocol PA-CL-05A
(Week 20 for Stage 1, Week 26 for Stage 2)) (central laboratory values).

3. Subjects with hypocalcaemia (total serum calcium <1.9 mmol/L or
<7.6 mg/dL at the previous study visit in Protocol PA-CL-05A (Week 20
for Stage 1, Week 26 for Stage 2)) (central laboratory values).

4. Subjects with raised alanine aminotransferase or aspartate
aminotransferase >3 times the upper limit of the normal range at the
previous study visit in Protocol PA-CL-05A (Week 20 for Stage 1,
Week 24 for Stage 2) (central laboratory values).

5. Subjects taking any prohibited medications (see Section 7.7, Prohibited
Therapy and Concomitant Treatment, page 41).

6. Subjects who are pregnant (e.g., positive human chorionic gonadotropin
test at Week 20 Protocol PA-CL-05A), breast feeding or, if of childbearing
potential, not using adequate contraceptive precautions. Subjects must
agree to use adequate contraception during the study and for 1 month after
the last dose of the study medication.
Adequate methods of birth control are defined as those which result in a
low failure rate (i.e., less than 1% per year) when used consistently and
correctly such as implants, injectables, combined oral contraceptives, some
intra-uterine devices, sexual abstinence or vasectomised partner.
Non-childbearing potential includes being surgically sterilised at least
6 months prior to the study or post-menopausal, defined as amenorrhea for
at least 12 months.

7. Subjects with serum ferritin >2,000 mcg/L (>4.494 pmol/L) at the previous study visit in Protocol PA-CL-05A (Week 20 for Stage 1, Week 24 for Stage 2) (central laboratory values).

8. Subjects with any kind of disorder that compromises the ability of the
subject to give written informed consent and/or to comply with study
procedures.

Study & Design

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