Clinical trial NCT00824460: Study of Phosphate Levels in Patients With Chronic Kidney Disease
Official title: An Open-label, Randomised, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: Hemodialysis
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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 \< 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

Primary outcomes:
measure: Change From Baseline in Serum-phosphate Levels at the End of Treatment.
timeFrame: 6 weeks after baseline
Secondary outcomes:
measure: Change From Baseline in Serum-phosphate Levels at Week 2
timeFrame: 2 weeks after baseline
measure: Change From Baseline in Serum-phosphate Levels at Week 4
timeFrame: 4 weeks after baseline
measure: Change From Baseline in Serum-phosphate Levels at Week 5
timeFrame: 5 weeks after baseline
Other outcomes:
Locations:
city: Arvada
country: United States
facility: Western Nephrology & Metabolic Disease
state: Colorado
city: Denver
country: United States
facility: Complete Renal Care
state: Colorado
city: Pembroke Pines
country: United States
facility: Pines Clinical Research
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Fresh Meadows
country: United States
facility: Nephrology Associates
state: New York
city: Cleveland
country: United States
facility: University Hospitals / Case Medical Center
state: Ohio
city: Chattanooga
country: United States
facility: Southeast Renal Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Nephrology Associates
state: Tennessee
city: Houston
country: United States
facility: Southwest Houston Research
state: Texas
city: Gabrovo
country: Bulgaria
facility: MHAT
city: Plovdiv
country: Bulgaria
facility: MHAT Plovdiv
city: Ruse
country: Bulgaria
facility: Department of Haemodialysis at MHAT
city: Sofia
country: Bulgaria
facility: 5th MHAT Sofia
city: Sofia
country: Bulgaria
facility: SHATCVD - National Cardiology Hospital
city: Sofia
country: Bulgaria
facility: MHAT "Tokuda Hospital Sofia"
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska" Dialysis Clinic
city: Sofia
country: Bulgaria
facility: UMHAT "Sveti Ivan Rilski"
city: Sofia
country: Bulgaria
facility: UMHAT "Sveta Anna"
city: Veliko Tarnovo
country: Bulgaria
facility: MDHAT Department of Haemodialysis and Nephrology
city: Bjelovar
country: Croatia
facility: Opca bonica Bjelovar
city: Karlovac
country: Croatia
facility: Opca bolnica Karlovac
city: Koprivnica
country: Croatia
facility: Opca bolnica
city: Osijek
country: Croatia
facility: Klinicka bolnica Osijek
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka
city: Split
country: Croatia
facility: Klinicki bolnicki centar Split
city: Zadar
country: Croatia
facility: Opca bolnica Zadar
city: Zagreb
country: Croatia
facility: Klinicka bolnica
city: Zagreb
country: Croatia
facility: Poliklinika Sveti Duh II
city: Zagreb
country: Croatia
facility: Klinicka bolnica Dubrava
city: Brno
country: Czech Republic
facility: Innef a.s. Hemodialyzancni stredisko
city: Nove Město na Morave
country: Czech Republic
facility: Nemocnice Nove Mesto na Morave
city: Novy Jicin
country: Czech Republic
facility: Nemocnice s poliklinikou v Novem Jicine
city: Prague
country: Czech Republic
facility: Klinika nefrologie VFN
city: Dortmund
country: Germany
facility: Nephrologische Gemeinschaftspraxis und Dialysezentrum
city: Herne
country: Germany
facility: Marienhospital
city: Golub-Dobrzyń
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Katowice
country: Poland
facility: Katedra i Klinika Nefrologii
city: Olkusz
country: Poland
facility: NZOZ Dializa
city: Poznań
country: Poland
facility: Katedra i Klinika Nefrologii
city: Siedlce
country: Poland
facility: Samodzielny Specjalistyczny
city: Sieradz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Centrum Dializy i Diagnostyki
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Lasi
country: Romania
facility: Spitalul Clinic
city: Oradea
country: Romania
facility: SC Renamed Nefrodial SRL
city: Targu Mures
country: Romania
facility: S.C. Avitum S.R.L
city: Kazan
country: Russian Federation
facility: GOU VPO Kazan
city: Moscow
country: Russian Federation
facility: GUZ City Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: MUZ City Clinical Hospital
city: Smolensk
country: Russian Federation
facility: MLPU Clinical City Hospital
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg CUS City Mariinskaya Hospital
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg GUZ City Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: GOU VPO
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg GUZ City Hospital
city: St. Petersburg
country: Russian Federation
facility: GOU VPO
city: St.Petersburg
country: Russian Federation
facility: CUS City Hospital
city: Aarau
country: Switzerland
facility: Kantonspital Aarau
city: Lausanne
country: Switzerland
facility: Chuv Lausanne
city: Zürich
country: Switzerland
facility: Universitatsspital Zurich
Study officials:
affiliation: Unafilliated
name: Prof. Rudolf P Wutrich, MD
role: PRINCIPAL_INVESTIGATOR
References: