CompletedNCT00824460PA21Updated Apr 1, 2014Results posted

Study of Phosphate Levels in Patients With Chronic Kidney Disease

A Phase 2 interventional study of 1.25 g PA21 (250 mg iron) and 5.0 g PA21 (1,000 mg iron) in Chronic Kidney Disease, sponsored by Vifor Pharma. Completed at 60 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-01.

Sponsored by Vifor Pharma · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 154
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Chronic Kidney Disease

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Keywords

Hemodialysis

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 154 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Vifor Pharma is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 154 participants (actual)

Study arms

Experimental
1.25 g PA21
Drug: 1.25 g PA21 (250 mg iron)
Experimental
5.0 g PA21
Drug: 5.0 g PA21 (1,000 mg iron)
Experimental
7.5 g PA21
Drug: 7.5 g PA21 (1,500 mg iron)
Experimental
10.0 g PA21
Drug: 10.0 g PA21 (2,000 mg iron)
Experimental
12.5 g PA21
Drug: 12.5 g PA21 (2,500 mg iron)
Experimental
Sevelamer hydrochloride - active control
Drug: Sevelamer hydrochloride

Interventions

Drug1.25 g PA21 (250 mg iron)
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.
Drug5.0 g PA21 (1,000 mg iron)
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).
Drug7.5 g PA21 (1,500 mg iron)
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).
Drug10.0 g PA21 (2,000 mg iron)
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).
Drug12.5 g PA21 (2,500 mg iron)
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).
DrugSevelamer hydrochloride
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).

What researchers measure

Primary outcomes

Change From Baseline in Serum-phosphate Levels at the End of Treatment.
Time frame: 6 weeks after baseline

Secondary outcomes

Change From Baseline in Serum-phosphate Levels at Week 2
Time frame: 2 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 4
Time frame: 4 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 5
Time frame: 5 weeks after baseline

Results

Posted Apr 1, 2014

Participant flow

Participant flow — Overall Study
Milestone	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 - Active Control
Started	26	26	25	27	24	26
Completed	18	17	20	15	15	18
Not completed	8	9	5	12	9	8

Outcome measures

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

Time frame:: 6 weeks after baseline
Reported as:: Mean · mmol/L

Change From Baseline in Serum-phosphate Levels at the End of Treatment.
mmol/L	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)	12.5g PA21 (2,500 mg Iron)	Sevelamer Hydrochloride - Active Control
Change From Baseline in Serum-phosphate Levels at the End of Treatment.	-0.042 ± 0.650	-0.348 ± 0.684	-0.404 ± 0.391	-0.644 ± 0.551	-0.547 ± 0.584	-0.341 ± 0.436

SecondaryChange From Baseline in Serum-phosphate Levels at Week 2

Time frame:: 2 weeks after baseline
Reported as:: Mean · mmol/L

Change From Baseline in Serum-phosphate Levels at Week 2
mmol/L	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 - Active Control
Change From Baseline in Serum-phosphate Levels at Week 2	-0.03 ± 0.55	-0.36 ± 0.35	-0.41 ± 0.40	-0.47 ± 0.62	-0.46 ± 0.45	-0.41 ± 0.44

SecondaryChange From Baseline in Serum-phosphate Levels at Week 4

Time frame:: 4 weeks after baseline
Reported as:: Mean · mmol/L

Change From Baseline in Serum-phosphate Levels at Week 4
mmol/L	1.25 g PA21 (250 mg Iron)	5.0g PA21 (1,000 mg Iron)	7.5 g PA21 (1,500 mg Iron)	10.0 g PA21 (2,000 mg Iron)	12.5g PA21 (2,500 mg Iron)	Sevelamer Hydrochloride - Active Control
Change From Baseline in Serum-phosphate Levels at Week 4	-0.03 ± 0.39	-0.39 ± 0.45	-0.32 ± 0.54	-0.58 ± 0.53	-0.53 ± 0.48	-0.53 ± 0.35

SecondaryChange From Baseline in Serum-phosphate Levels at Week 5

Time frame:: 5 weeks after baseline
Reported as:: Mean · mmol/L

Change From Baseline in Serum-phosphate Levels at Week 5
mmol/L	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 - Active Control
Change From Baseline in Serum-phosphate Levels at Week 5	-0.05 ± 0.62	-0.51 ± 0.62	-0.40 ± 0.33	-0.57 ± 0.55	-0.58 ± 0.58	-0.52 ± 0.37

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1.25 g PA21 (250 mg Iron)	—	2/26 (7.7%)	13/26 (50%)
5.0 g PA21 (1,000 mg Iron)	—	2/26 (7.7%)	16/26 (61.5%)
7.5 g PA21 (1,500 mg Iron)	—	1/25 (4%)	13/25 (52%)
10.0 g PA21 (2,000 mg Iron)	—	1/27 (3.7%)	18/27 (66.7%)
12.5 g PA21 (2,500 mg Iron)	—	2/24 (8.3%)	17/24 (70.8%)
Sevelamer Hydrochloride - Active Control	—	2/26 (7.7%)	13/26 (50%)

Most frequent serious events

Most frequent serious events
Event	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 - Active Control
Staphylococcal sepsisInfections and infestations	0/26	1/26	0/25	0/27	1/24	0/26
Fluid overloadMetabolism and nutrition disorders	0/26	0/26	0/25	0/27	1/24	0/26
Ischaemic strokeNervous system disorders	0/26	0/26	1/25	0/27	0/24	0/26
AsthmaRespiratory, thoracic and mediastinal disorders	1/26	0/26	0/25	0/27	0/24	0/26
Diverticular perforationGastrointestinal disorders	1/26	0/26	0/25	0/27	0/24	0/26
Myocardial infarctionCardiac disorders	0/26	1/26	0/25	0/27	0/24	0/26
CholelithiasisHepatobiliary disorders	0/26	0/26	0/25	0/27	0/24	1/26
Diabetic retinopathyEye disorders	0/26	0/26	0/25	0/27	0/24	1/26
Rib fractureInjury, poisoning and procedural complications	0/26	0/26	0/25	1/27	0/24	0/26

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	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 - Active Control
HypophosphataemiaMetabolism and nutrition disorders	2/26	4/26	2/25	8/27	7/24	2/26
HyperphosphataemiaMetabolism and nutrition disorders	4/26	3/26	1/25	1/27	0/24	2/26
Faeces DiscoloureGastrointestinal disorders	2/26	3/26	3/25	4/27	3/24	0/26
Muscle SpasmsMusculoskeletal and connective tissue disorders	1/26	1/26	2/25	1/27	3/24	0/26
AnaemiaBlood and lymphatic system disorders	0/26	0/26	3/25	0/27	0/24	0/26
HypotensionVascular disorders	0/26	1/26	0/25	0/27	0/24	3/26
HypertensionVascular disorders	1/26	0/26	2/25	0/27	2/24	1/26
NasopharyngitisInfections and infestations	0/26	0/26	0/25	0/27	2/24	0/26
DiarrhoeaGastrointestinal disorders	1/26	2/26	2/25	1/27	1/24	2/26
HypercalcaemiaMetabolism and nutrition disorders	2/26	2/26	1/25	1/27	1/24	2/26

Baseline characteristics

For baseline characteristics data, from All Randomised patients was used.

Age, Categorical
Age, Categorical(Participants)	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)	12.5g PA21 (2,500 mg Iron)	Sevelamer Hydrochloride - Active Control	Total
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	14	18	14	17	14	16	93
>=65 years	12	8	11	10	10	10	61

Age, Continuous
Age, Continuous(years)	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)	12.5g PA21 (2,500 mg Iron)	Sevelamer Hydrochloride - Active Control	Total
Mean	60.1 ± 12.29	59.7 ± 13.80	61.9 ± 13.71	60.6 ± 12.74	59.3 ± 12.32	61.1 ± 11.00	60.5 ± 12.50

Sex: Female, Male
Sex: Female, Male(Participants)	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)	12.5g PA21 (2,500 mg Iron)	Sevelamer Hydrochloride - Active Control	Total
Female	9	7	9	10	11	11	57
Male	17	19	16	17	13	15	97

Region of Enrollment
Region of Enrollment(participants)	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)	12.5g PA21 (2,500 mg Iron)	Sevelamer Hydrochloride - Active Control	Total
United States	4	4	3	4	2	4	21
Czech Republic	0	3	0	0	3	2	8
Poland	4	2	3	2	0	4	15
Romania	2	4	2	3	1	0	12
Croatia	5	3	9	8	8	7	40
Russian Federation	7	5	3	5	2	6	28
Bulgaria	3	3	5	4	7	1	23
Germany	1	0	0	0	0	1	2
Switzerland	0	2	0	1	1	1	5

Study locations

60 sites

Western Nephrology & Metabolic Disease
Arvada, Colorado 80002, United States
Complete Renal Care
Denver, Colorado 80220, United States
Pines Clinical Research
Pembroke Pines, Florida 33028, United States
University of Kansas Medical Center
Kansas City, Kansas 66160, United States
Nephrology Associates
Fresh Meadows, New York 11365, United States
University Hospitals / Case Medical Center
Cleveland, Ohio 44106, United States
Southeast Renal Research Institute
Chattanooga, Tennessee 37404, United States
Nephrology Associates
Nashville, Tennessee 37205, United States
Southwest Houston Research
Houston, Texas 77099, United States
MHAT
Gabrovo, 5300, Bulgaria
MHAT Plovdiv
Plovdiv, 4003, Bulgaria
Department of Haemodialysis at MHAT
Ruse, 7002, Bulgaria
5th MHAT Sofia
Sofia, 1233, Bulgaria
SHATCVD - National Cardiology Hospital
Sofia, 1309, Bulgaria
MHAT "Tokuda Hospital Sofia"
Sofia, 1407, Bulgaria
UMHAT "Alexandrovska" Dialysis Clinic
Sofia, 1431, Bulgaria
UMHAT "Sveti Ivan Rilski"
Sofia, 1431, Bulgaria
UMHAT "Sveta Anna"
Sofia, 1784, Bulgaria
MDHAT Department of Haemodialysis and Nephrology
Veliko Tarnovo, 5000, Bulgaria
Opca bonica Bjelovar
Bjelovar, 43000, Croatia
Opca bolnica Karlovac
Karlovac, 47000, Croatia
Opca bolnica
Koprivnica, 48000, Croatia
Klinicka bolnica Osijek
Osijek, 31000, Croatia
Klinicki bolnicki centar Rijeka
Rijeka, 51000, Croatia
Klinicki bolnicki centar Split
Split, 21000, Croatia
Opca bolnica Zadar
Zadar, 23000, Croatia
Klinicka bolnica
Zagreb, 10000, Croatia
Poliklinika Sveti Duh II
Zagreb, 10000, Croatia
Klinicka bolnica Dubrava
Zagreb, 10040, Croatia
Innef a.s. Hemodialyzancni stredisko
Brno, 60200, Czech Republic
Nemocnice Nove Mesto na Morave
Nove Město na Morave, 59231, Czech Republic
Nemocnice s poliklinikou v Novem Jicine
Novy Jicin, 74101, Czech Republic
Klinika nefrologie VFN
Prague, 2, Czech Republic
Nephrologische Gemeinschaftspraxis und Dialysezentrum
Dortmund, 44263, Germany
Marienhospital
Herne, 44625, Germany
Niepubliczny Zaklad Opieki Zdrowotnej
Golub-Dobrzyń, 87-400, Poland
Katedra i Klinika Nefrologii
Katowice, 40-027, Poland
NZOZ Dializa
Olkusz, 32-300, Poland
Katedra i Klinika Nefrologii
Poznań, 60-355, Poland
Samodzielny Specjalistyczny
Siedlce, 26, Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Sieradz, 98-200, Poland
Centrum Dializy i Diagnostyki
Warszawa, 01-809, Poland
Institutul Clinic Fundeni
Bucuresti, 022328, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucuresti, 050098, Romania
Spitalul Clinic
Lasi, 700503, Romania
SC Renamed Nefrodial SRL
Oradea, 410562, Romania
S.C. Avitum S.R.L
Targu Mures, 540136, Romania
GOU VPO Kazan
Kazan, 420064, Russian Federation
GUZ City Clinical Hospital
Moscow, 125284, Russian Federation
MUZ City Clinical Hospital
Novosibirsk, 630120, Russian Federation
MLPU Clinical City Hospital
Smolensk, 214001, Russian Federation
Saint-Petersburg CUS City Mariinskaya Hospital
St. Petersburg, 191104, Russian Federation
Saint-Petersburg GUZ City Clinical Hospital
St. Petersburg, 195257, Russian Federation
GOU VPO
St. Petersburg, 195607, Russian Federation
Saint-Petersburg GUZ City Hospital
St. Petersburg, 196247, Russian Federation
GOU VPO
St. Petersburg, 197089, Russian Federation
CUS City Hospital
St.Petersburg, 198205, Russian Federation
Kantonspital Aarau
Aarau, 5001, Switzerland
Chuv Lausanne
Lausanne, 1011, Switzerland
Universitatsspital Zurich
Zürich, 8091, Switzerland

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00824460
Lead sponsor: Vifor Pharma
Responsible party: Sponsor
First posted: Jan 16, 2009
Start date: Dec 2008
Primary completion: Oct 2009
Completion: Mar 2010
Results posted: Apr 1, 2014
Last update: Apr 1, 2014

Study contacts

Prof. Rudolf P Wutrich, MD

principal investigator · Unafilliated

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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