Phase 2
N=154
Study of Phosphate Levels in Patients With Chronic Kidney Disease
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT00824460 ↗Enrolled (actual)
154
Serious AEs
6.5%
Results posted
Apr 2014
Primary outcome: Primary: Change From Baseline in Serum-phosphate Levels at the End of Treatment. — -0.042; -0.348; -0.404; -0.644 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 1.25 g PA21 (250 mg iron) (Drug); 5.0 g PA21 (1,000 mg iron) (Drug); 7.5 g PA21 (1,500 mg iron) (Drug); 10.0 g PA21 (2,000 mg iron) (Drug); 12.5 g PA21 (2,500 mg iron) (Drug); Sevelamer hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vifor Pharma
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Serum-phosphate Levels at the End of Treatment. |
-0.042; -0.348; -0.404; -0.644; -0.547; -0.341 | — |
| SECONDARY Change From Baseline in Serum-phosphate Levels at Week 2 |
-0.03; -0.36; -0.41; -0.47; -0.46; -0.41 | — |
| SECONDARY Change From Baseline in Serum-phosphate Levels at Week 4 |
-0.03; -0.39; -0.32; -0.58; -0.53; -0.53 | — |
| SECONDARY Change From Baseline in Serum-phosphate Levels at Week 5 |
-0.05; -0.51; -0.40; -0.57; -0.58; -0.52 | — |
Summary
The purpose of this study is to investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.
Eligibility Criteria
Main Inclusion Criteria:
- ≥ 18 years of age,
- Receiving stable maintenance hemodialysis 3 times a week
- On restricted phosphate diet at screening and throughout study
- Receiving stable dose of phosphate binder for at least 1 month
- Serum phosphate levels >1.78 mmol/L
Main Exclusion Criteria:
- Uncontrolled hyperphosphatemia
- Hypercalcemia at screening or during washout
- Serum calcium 600 ng/L)
- Pregnancy or lactation
- Iron deficiency anemia
- History of hemochromatosis or ferritin >800 mg/L,
- Hepatitis B, hepatitis C or other significant concurrent liver disorders
- Known positivity to HIV
- Use of oral iron preparations 1 month before screening,
- Serious medical condition or uncontrolled systemic disease
Data sourced from ClinicalTrials.gov (NCT00824460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.