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Study of Phosphate Levels in Patients With Chronic Kidney Disease (PA21)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
1.25 g PA21 (250 mg iron)
5.0 g PA21 (1,000 mg iron)
7.5 g PA21 (1,500 mg iron)
10.0 g PA21 (2,000 mg iron)
12.5 g PA21 (2,500 mg iron)
Sevelamer hydrochloride
Sponsored by
Vifor Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western Nephrology & Metabolic Disease
  • Complete Renal Care
  • Pines Clinical Research
  • University of Kansas Medical Center
  • Nephrology Associates
  • University Hospitals / Case Medical Center
  • Southeast Renal Research Institute
  • Nephrology Associates
  • Southwest Houston Research
  • MHAT
  • MHAT Plovdiv
  • Department of Haemodialysis at MHAT
  • 5th MHAT Sofia
  • SHATCVD - National Cardiology Hospital
  • MHAT "Tokuda Hospital Sofia"
  • UMHAT "Alexandrovska" Dialysis Clinic
  • UMHAT "Sveti Ivan Rilski"
  • UMHAT "Sveta Anna"
  • MDHAT Department of Haemodialysis and Nephrology
  • Opca bonica Bjelovar
  • Opca bolnica Karlovac
  • Opca bolnica
  • Klinicka bolnica Osijek
  • Klinicki bolnicki centar Rijeka
  • Klinicki bolnicki centar Split
  • Opca bolnica Zadar
  • Klinicka bolnica
  • Poliklinika Sveti Duh II
  • Klinicka bolnica Dubrava
  • Innef a.s. Hemodialyzancni stredisko
  • Nemocnice Nove Mesto na Morave
  • Nemocnice s poliklinikou v Novem Jicine
  • Klinika nefrologie VFN
  • Nephrologische Gemeinschaftspraxis und Dialysezentrum
  • Marienhospital
  • Niepubliczny Zaklad Opieki Zdrowotnej
  • Katedra i Klinika Nefrologii
  • NZOZ Dializa
  • Katedra i Klinika Nefrologii
  • Samodzielny Specjalistyczny
  • Niepubliczny Zaklad Opieki Zdrowotnej
  • Centrum Dializy i Diagnostyki
  • Institutul Clinic Fundeni
  • Spitalul Universitar de Urgenta Bucuresti
  • Spitalul Clinic
  • SC Renamed Nefrodial SRL
  • S.C. Avitum S.R.L
  • GOU VPO Kazan
  • GUZ City Clinical Hospital
  • MUZ City Clinical Hospital
  • MLPU Clinical City Hospital
  • Saint-Petersburg CUS City Mariinskaya Hospital
  • Saint-Petersburg GUZ City Clinical Hospital
  • GOU VPO
  • Saint-Petersburg GUZ City Hospital
  • GOU VPO
  • CUS City Hospital
  • Kantonspital Aarau
  • Chuv Lausanne
  • Universitatsspital Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1.25 g PA21

5.0 g PA21

7.5 g PA21

10.0 g PA21

12.5 g PA21

Sevelamer hydrochloride - active control

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Serum-phosphate Levels at the End of Treatment.

Secondary Outcome Measures

Change From Baseline in Serum-phosphate Levels at Week 2
Change From Baseline in Serum-phosphate Levels at Week 4
Change From Baseline in Serum-phosphate Levels at Week 5

Full Information

First Posted
January 9, 2009
Last Updated
March 3, 2014
Sponsor
Vifor Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00824460
Brief Title
Study of Phosphate Levels in Patients With Chronic Kidney Disease
Acronym
PA21
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

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.25 g PA21
Arm Type
Experimental
Arm Title
5.0 g PA21
Arm Type
Experimental
Arm Title
7.5 g PA21
Arm Type
Experimental
Arm Title
10.0 g PA21
Arm Type
Experimental
Arm Title
12.5 g PA21
Arm Type
Experimental
Arm Title
Sevelamer hydrochloride - active control
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
1.25 g PA21 (250 mg iron)
Intervention Description
Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.
Intervention Type
Drug
Intervention Name(s)
5.0 g PA21 (1,000 mg iron)
Intervention Description
Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Intervention Type
Drug
Intervention Name(s)
7.5 g PA21 (1,500 mg iron)
Intervention Description
Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).
Intervention Type
Drug
Intervention Name(s)
10.0 g PA21 (2,000 mg iron)
Intervention Description
Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Intervention Type
Drug
Intervention Name(s)
12.5 g PA21 (2,500 mg iron)
Intervention Description
Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).
Intervention Type
Drug
Intervention Name(s)
Sevelamer hydrochloride
Intervention Description
Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).
Primary Outcome Measure Information:
Title
Change From Baseline in Serum-phosphate Levels at the End of Treatment.
Time Frame
6 weeks after baseline
Secondary Outcome Measure Information:
Title
Change From Baseline in Serum-phosphate Levels at Week 2
Time Frame
2 weeks after baseline
Title
Change From Baseline in Serum-phosphate Levels at Week 4
Time Frame
4 weeks after baseline
Title
Change From Baseline in Serum-phosphate Levels at Week 5
Time Frame
5 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Rudolf P Wutrich, MD
Organizational Affiliation
Unafilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Nephrology & Metabolic Disease
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Complete Renal Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Pines Clinical Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Nephrology Associates
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
University Hospitals / Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Southeast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Nephrology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Southwest Houston Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
MHAT
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
MHAT Plovdiv
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Department of Haemodialysis at MHAT
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
5th MHAT Sofia
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
SHATCVD - National Cardiology Hospital
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
MHAT "Tokuda Hospital Sofia"
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT "Alexandrovska" Dialysis Clinic
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT "Sveti Ivan Rilski"
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT "Sveta Anna"
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
MDHAT Department of Haemodialysis and Nephrology
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Opca bonica Bjelovar
City
Bjelovar
ZIP/Postal Code
43000
Country
Croatia
Facility Name
Opca bolnica Karlovac
City
Karlovac
ZIP/Postal Code
47000
Country
Croatia
Facility Name
Opca bolnica
City
Koprivnica
ZIP/Postal Code
48000
Country
Croatia
Facility Name
Klinicka bolnica Osijek
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
Facility Name
Klinicki bolnicki centar Rijeka
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
Facility Name
Klinicki bolnicki centar Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Facility Name
Opca bolnica Zadar
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Facility Name
Klinicka bolnica
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Poliklinika Sveti Duh II
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka bolnica Dubrava
City
Zagreb
ZIP/Postal Code
10040
Country
Croatia
Facility Name
Innef a.s. Hemodialyzancni stredisko
City
Brno
ZIP/Postal Code
60200
Country
Czech Republic
Facility Name
Nemocnice Nove Mesto na Morave
City
Nove Město na Morave
ZIP/Postal Code
59231
Country
Czech Republic
Facility Name
Nemocnice s poliklinikou v Novem Jicine
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czech Republic
Facility Name
Klinika nefrologie VFN
City
Prague
ZIP/Postal Code
2
Country
Czech Republic
Facility Name
Nephrologische Gemeinschaftspraxis und Dialysezentrum
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
Facility Name
Marienhospital
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej
City
Golub-Dobrzyń
ZIP/Postal Code
87-400
Country
Poland
Facility Name
Katedra i Klinika Nefrologii
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
NZOZ Dializa
City
Olkusz
ZIP/Postal Code
32-300
Country
Poland
Facility Name
Katedra i Klinika Nefrologii
City
Poznań
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Samodzielny Specjalistyczny
City
Siedlce
ZIP/Postal Code
26
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej
City
Sieradz
ZIP/Postal Code
98-200
Country
Poland
Facility Name
Centrum Dializy i Diagnostyki
City
Warszawa
ZIP/Postal Code
01-809
Country
Poland
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Spitalul Clinic
City
Lasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
SC Renamed Nefrodial SRL
City
Oradea
ZIP/Postal Code
410562
Country
Romania
Facility Name
S.C. Avitum S.R.L
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
GOU VPO Kazan
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
GUZ City Clinical Hospital
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
MUZ City Clinical Hospital
City
Novosibirsk
ZIP/Postal Code
630120
Country
Russian Federation
Facility Name
MLPU Clinical City Hospital
City
Smolensk
ZIP/Postal Code
214001
Country
Russian Federation
Facility Name
Saint-Petersburg CUS City Mariinskaya Hospital
City
St. Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Saint-Petersburg GUZ City Clinical Hospital
City
St. Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
GOU VPO
City
St. Petersburg
ZIP/Postal Code
195607
Country
Russian Federation
Facility Name
Saint-Petersburg GUZ City Hospital
City
St. Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
GOU VPO
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
CUS City Hospital
City
St.Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Kantonspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Chuv Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Universitatsspital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Study of Phosphate Levels in Patients With Chronic Kidney Disease

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