Status:
COMPLETED
Study of Phosphate Levels in Patients With Chronic Kidney Disease
Lead Sponsor:
Vifor Pharma
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
Inclusion
- Main
- ≥ 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
- Uncontrolled hyperphosphatemia
- Hypercalcemia at screening or during washout
- Serum calcium \< 1.9 mmol/L (\<7.6 mg/dL)
- Severe hyperparathyroidism (iPTH levels \>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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00824460
Start Date
December 1 2008
End Date
March 1 2010
Last Update
April 1 2014
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
Western Nephrology & Metabolic Disease
Arvada, Colorado, United States, 80002
2
Complete Renal Care
Denver, Colorado, United States, 80220
3
Pines Clinical Research
Pembroke Pines, Florida, United States, 33028
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160