An open-label, randomized, active controlled multi center phase II dose finding study to evaluate the ability of PA21 to lower serum phosphate levels and the tolerability in patients with chronic kidney disease on maintenance hemodialysis

• Conditions: Hyperphosphatemia in patients with chronic kidney disease on maintenance hemodialysis; MedDRA version: 9.1Level: LLTClassification code 10020712Term: Hyperphosphatemia

• Registration Number: EUCTR2008-004748-36-BG
• Lead Sponsor: Vifor (International) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-29
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Able to provide written informed consent.
2. Men and women = 18 years of age,
3. Receiving stable maintenance hemodialysis 3 times a week for = 3 months before screening,
4. Being on restricted phosphate diet at screening and throughout study, and being compliant with prescribed phosphate binders, as per Investigator judgment,
5. Receiving stable doses of phosphate binder for at least 1 month before screening,
6. Patients receiving therapy with vitamin D, vitamin D metabolites or calcimimetics must be on a constant dose for a least 1 month prior to screening and must remain on the same dose throughout the study,
7. Having stable calcium content in dialysate for at least 1 month prior to screening,
8. Able to read and write with sufficient competence to understand the study procedures and capable of giving legal consent,
9. Patients who receive therapy with erythropoietin must be on a constant dose for at least 1 month before screening and must remain on the same dose throughout the study,
To be eligible for randomization and to enter into the treatment period, the patients must have:
10. Serum phosphate levels >1.78 mmol/L (5.5 mg/dL) (Value at Week -1, D2 or D3). If the serum phosphate level is > 1.78 mmol/L (>5.5 mg/dL) already at Week 1, D2, then the patient can be randomized (in Week 1, D1) without waiting for the results of the serum phosphate level at Week 1, D3.

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

Patients cannot be enrolled in this study if they meet one or more of the following exclusion criteria:
1. Uncontrolled hyperphosphatemia (>2.5 mmol/L [7.75 mg/dL]) while on conventional phosphate binders (value at screening),
2. Hypercalcemia (serum calcium >2.5 mmol/L [>10.0 mg/dL]) at screening or during washout,
3. Serum calcium < 1.9 mmol/L (<7.6 mg/dL) at screening or during washout,
4. Severe hyperparathyroidism (iPTH levels >600 ng/L),
5. Intention to initiate therapy with vitamin D, vitamin D metabolites or calcimimetics during the study or / and non-stable therapy with vitamin D, vitamin D metabolites or calcimimetics (if applicable),
6. Known history of non-response to phosphate binders,
7. Known hypersensitivity to PA21, sevelamer (as Renagel® or Renvela®), or to any of their excipients, or iron allergy,
8. Pregnancy or lactation (patients with a positive pregnancy test will leave the study and may be rescreened once about 2 weeks after the first pregnancy test, to rule out a false positive pregnancy test),
9. Iron deficiency anemia defined as hemoglobin < 10 g/dL and (ferritin < 100 ng/mL or Transferrin saturation [TFS] < 20%) at screening,
10. History of hemochromatosis or ferritin >800 ?g/L,
11. Lack of highly effective contraception in female patients of child-bearing potential:
This exclusion criterion excludes any woman or man who is not currently using or is not willing to continue to use a highly effective method of birth control (see next paragraph) or is sexually abstinent, unless she is surgically sterilized (tubal ligation and/or hysterectomy), post menopausal (amenorrhea for at least 1 year before screening) or has a vasectomized partner.
A hormonal contraceptive drug (the pill” or a 3-month injection), an IUD (loop) or sterilization is considered an effective contraceptive method that has been taken for at least 2 months before study entry. If these do not apply, the patient can also use an IUD and a condom (for the male partner).
Men who are sexually active and have not been sterilized surgically must use a condom during intercourse and ensure, in addition, that the female partner uses a reliable contraceptive method, or they must refrain from sexual intercourse during the entire clinical study. This is to prevent a pregnancy from possibly damaged sperm. Therefore, patients must not conceive a child during the clinical study and for up to 1 month after the intake of the study drug.
12. Significant gastrointestinal disorder (including known active peptic ulcer, Crohn’s disease, ulcerative colitis, irritable bowel syndrome, motility disorder of the intestines [symptomatic gastroparesis {treated or untreated}, ileus, severe constipation, pseudo obstruction, megacolon, or mechanical obstruction], and history of major gastrointestinal surgery),
13. Hepatitis B (hepatitis B surface antigen [HBsAg] positivity only), hepatitis C (hepatitis C virus ribonucleic acid [HCV RNA] positivity only, patients with negative HCV RNA test can be enrolled) or other significant concurrent liver disorders (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 3 times the upper limit of the normal range),
14. Known seropositivity to human immunodeficiency virus (HIV),
15. Active infection or is being treated with antibiotics at screening,
Patients who are treated with antibiotics will leave the study and may be rescreened once the infection is resolved and the treatment with antibiotics finished.
16. Intention to c

Study & Design

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