A Phase 3 study to investigate the safety and efficacy of PA21, a phosphate binder, in dialysis patients with hyperphosphatemia

• Conditions: Control of hyperphosphataemia in patients with chronic kidney disease on dialysis; MedDRA version: 14.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 14.0Level: PTClassification code 10020711Term: HyperphosphataemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2010-022011-19-LT
• Lead Sponsor: Vifor (International) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-15
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 940

Inclusion Criteria

1.Subjects receiving maintenance HD 3 times/week with a Kt/V of =1.2 or peritoneal dialysis (PD) with a Kt/V of =1.7 within the last 3 months prior to screening. No home HD or nocturnal HD (overnight stay at site) will be allowed.

2.Subjects with a history of hyperphosphataemia and receiving stable doses of a phosphate binder(s) for at least 1 month prior to screening. Subjects may be on stable doses of 1 or 2 phosphate binders.

3.Male and female adult subjects (aged =18 years at time of consent).

4.Subjects with serum phosphate levels =1.94 mmol/L (=6.0 mg/dL) at any time during the washout period.

5.Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessments, in the Investigator’s opinion.

6.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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 564
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 376

Exclusion Criteria

1.Subjects with intact parathyroid hormone (iPTH) levels >800 ng/L (>800 pg/ml or 88 pmol/L) at screening. Subjects with iPTH >600 ng/L (>600 pg/ml or 66 pmol/L) at screening must be considered stable in the Investigator’s opinion.

2.Subjects with planned or expected parathyroidectomy within the next 12 months, in the Investigator’s opinion.

3.Subjects with anticipated need for major surgery during the study that may be associated with increased risk to the subject, or may interfere with study assessments or outcomes, or the ability to provide written informed consent or comply with study procedures, in the Investigator’s opinion.

4.Subjects with history (within 3 years of screening) of:
?Major gastrointestinal surgery likely to influence the outcome of treatment with phosphate binders
?Significant gastrointestinal or hepatic disorders

5.Subjects currently with, in the Investigator’s opinion:
?Unstable angina
?Unstable hypertension
?Uncontrolled diabetes
?Estimated life expectancy of less than 12 months
?Anticipated renal transplantation during study participation

6.Subjects with known seropositivity to human immunodeficiency virus.

7.Subjects with active hepatitis (hepatitis B or C surface antigen positive).

8.Subjects with significant medical conditions which, in the Investigator’s opinion, may be associated with increased risk to the subject, or may interfere with study assessments or outcomes, or the ability to provide informed consent or comply with study procedures.

9.Subjects with:
- A history of haemochromatosis or other iron accumulation disturbances that might lead to iron overload
- Serum ferritin >2,000 mcg/L (4,494 pmol/L) at screening.

10.Subjects on PD with a history of peritonitis in the last 3 months or =3 episodes in the last 12 months.

11.Subjects on non-calcium based phosphate binders with hypercalcaemia (total serum calcium >2.60 mmol/L or >10.50 mg/dL) at screening.

12.Subjects with hypocalcaemia (total serum calcium <1.9 mmol/L or <7.6 mg/dL) at screening.

13.Subjects with raised alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of the normal range at screening.

14.Subjects taking any prohibited medications (see Section 7.7, Prohibited Therapy and Concomitant Treatment, page 57).

15.Subjects taking more than 2 phosphate binders concomitantly prior to screening or subjects who are phosphate binder naïve prior to screening.

16.Subjects with a history of drug or alcohol abuse within 2 years before screening.

17.Subjects currently enrolled in or who have completed any other investigational device or drug study <30 days prior to screening, or subjects receiving other investigational agent(s).

18.Subjects who are pregnant (e.g., positive human chorionic gonadotropin test), breast feeding, or, if of child-bearing potential, are 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 child-bearing potential includes being surgically sterilised at least 6 months prior to the study or post menopausal, defined as amenorrhea for at

Study & Design

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