Chronic Kidney DiseasePhase 2PA21NCT00824460
Study of Phosphate Levels in Patients With Chronic Kidney Disease
A Phase 2 study testing 1.25 g PA21 (250 mg iron), 5.0 g PA21 (1,000 mg iron) and 7.5 g PA21 (1,500 mg iron) in people with Chronic Kidney Disease, run by Vifor Pharma at 60 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- 1.25 g PA21 (250 mg iron), 5.0 g PA21 (1,000 mg iron) and 7.5 g PA21 (1,500 mg iron)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 60 sitesin 9 countries
- Study dates
- Dec 2008to Mar 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
60 sites in 9 countries.
60 sites in 9 countries
Bulgaria10 sites
MHAT
Gabrovo, 5300
MHAT Plovdiv
Plovdiv, 4003
Department of Haemodialysis at MHAT
Rousse, 7002
5th MHAT Sofia
Sofia, 1233
SHATCVD - National Cardiology Hospital
Sofia, 1309
MHAT "Tokuda Hospital Sofia"
Sofia, 1407
UMHAT "Alexandrovska" Dialysis Clinic
Sofia, 1431
UMHAT "Sveti Ivan Rilski"
Sofia, 1431
UMHAT "Sveta Anna"
Sofia, 1784
MDHAT Department of Haemodialysis and Nephrology
Veliko Tarnovo, 5000
Croatia10 sites
Opca bonica Bjelovar
Bjelovar, 43000
Opca bolnica Karlovac
Karlovac, 47000
Opca bolnica
Koprivnica, 48000
Klinicka bolnica Osijek
Osijek, 31000
Klinicki bolnicki centar Rijeka
Rijeka, 51000
Klinicki bolnicki centar Split
Split, 21000
Opca bolnica Zadar
Zadar, 23000
Klinicka bolnica
Zagreb, 10000
Poliklinika Sveti Duh II
Zagreb, 10000
Klinicka bolnica Dubrava
Zagreb, 10040
Russia10 sites
GOU VPO Kazan
Kazan', 420064
GUZ City Clinical Hospital
Moscow, 125284
MUZ City Clinical Hospital
Novosibirsk, 630120
Saint-Petersburg CUS City Mariinskaya Hospital
Saint Petersburg, 191104
Saint-Petersburg GUZ City Clinical Hospital
Saint Petersburg, 195257
GOU VPO
Saint Petersburg, 195607
Saint-Petersburg GUZ City Hospital
Saint Petersburg, 196247
GOU VPO
Saint Petersburg, 197089
CUS City Hospital
Saint Petersburg, 198205
MLPU Clinical City Hospital
Smolensk, 214001
United States9 sites
Western Nephrology & Metabolic Disease
Arvada, Colorado, 80002
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404
University Hospitals / Case Medical Center
Cleveland, Ohio, 44106
Complete Renal Care
Denver, Colorado, 80220
Nephrology Associates
Fresh Meadows, New York, 11365
Southwest Houston Research
Houston, Texas, 77099
University of Kansas Medical Center
Kansas City, Kansas, 66160
Nephrology Associates
Nashville, Tennessee, 37205
Pines Clinical Research
Pembroke Pines, Florida, 33028
Poland7 sites
Niepubliczny Zaklad Opieki Zdrowotnej
Golub-Dobrzyń, 87-400
Katedra i Klinika Nefrologii
Katowice, 40-027
NZOZ Dializa
Olkusz, 32-300
Katedra i Klinika Nefrologii
Poznan, 60-355
Samodzielny Specjalistyczny
Siedlce, 26
Niepubliczny Zaklad Opieki Zdrowotnej
Sieradz, 98-200
Centrum Dializy i Diagnostyki
Warsaw, 01-809
Romania5 sites
Institutul Clinic Fundeni
Bucharest, 022328
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098
Spitalul Clinic
Lasi, 700503
SC Renamed Nefrodial SRL
Oradea, 410562
S.C. Avitum S.R.L
Târgu Mureş, 540136
Czechia4 sites
Innef a.s. Hemodialyzancni stredisko
Brno, 60200
Nemocnice Nove Mesto na Morave
Nove Město Na Morave, 59231
Nemocnice s poliklinikou v Novem Jicine
Nový Jičín, 74101
Klinika nefrologie VFN
Prague, 2
Switzerland3 sites
Kantonspital Aarau
Aarau, 5001
Chuv Lausanne
Lausanne, 1011
Universitatsspital Zurich
Zurich, 8091
Germany2 sites
Nephrologische Gemeinschaftspraxis und Dialysezentrum
Dortmund, 44263
Marienhospital
Herne, 44625
About this study
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
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
- Chronic Kidney Disease
- Being tested
- 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)
- Keywords
- Hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.25 g PA21 (250 mg iron)Drug
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.
5.0 g PA21 (1,000 mg iron)Drug
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).
7.5 g PA21 (1,500 mg iron)Drug
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).
10.0 g PA21 (2,000 mg iron)Drug
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).
12.5 g PA21 (2,500 mg iron)Drug
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).
Sevelamer hydrochlorideDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 1.25 g PA21 | Experimental | Not described Receives: Drug: 1.25 g PA21 (250 mg iron) |
| 5.0 g PA21 | Experimental | Not described Receives: Drug: 5.0 g PA21 (1,000 mg iron) |
| 7.5 g PA21 | Experimental | Not described Receives: Drug: 7.5 g PA21 (1,500 mg iron) |
| 10.0 g PA21 | Experimental | Not described Receives: Drug: 10.0 g PA21 (2,000 mg iron) |
| 12.5 g PA21 | Experimental | Not described Receives: Drug: 12.5 g PA21 (2,500 mg iron) |
| Sevelamer hydrochloride - active control | Experimental | Not described Receives: Drug: Sevelamer hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Serum-phosphate Levels at the End of Treatment.
Measured: 6 weeks after baseline
Secondary outcomes (3)
Change From Baseline in Serum-phosphate Levels at Week 2
Measured: 2 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 4
Measured: 4 weeks after baseline
Change From Baseline in Serum-phosphate Levels at Week 5
Measured: 5 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Rudolf P Wutrich, MD, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824460
- Sponsor's protocol ID
- PA-CL-03A
- Other IDs
- 75610
- Acronym
- PA21
- Status last verified
- Mar 2014
- First submitted
- 9 Jan 2009
- Last updated
- 1 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00824460
- Acronym / sponsor ID
- PA21 / PA-CL-03A
- Conditions
- Chronic Kidney Disease
- Keywords
- Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 1 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1.25 g PA21 | Experimental | Drug: 1.25 g PA21 (250 mg iron) |
| 5.0 g PA21 | Experimental | Drug: 5.0 g PA21 (1,000 mg iron) |
| 7.5 g PA21 | Experimental | Drug: 7.5 g PA21 (1,500 mg iron) |
| 10.0 g PA21 | Experimental | Drug: 10.0 g PA21 (2,000 mg iron) |
| 12.5 g PA21 | Experimental | Drug: 12.5 g PA21 (2,500 mg iron) |
| Sevelamer hydrochloride - active control | Experimental | Drug: Sevelamer hydrochloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1.25 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. | Drug | 1.25 g PA21 |
| 5.0 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). | Drug | 5.0 g PA21 |
| 7.5 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). | Drug | 7.5 g PA21 |
| 10.0 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). | Drug | 10.0 g PA21 |
| 12.5 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). | Drug | 12.5 g PA21 |
| Sevelamer hydrochlorideDaily 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). | Drug | Sevelamer hydrochloride - active control |
Primary outcome
Change From Baseline in Serum-phosphate Levels at the End of Treatment.
Time frame: 6 weeks after baseline
3 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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Rudolf P Wutrich, MD principal investigator
Unafilliated
60 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1.25 g PA21 (250 mg iron), 5.0 g PA21 (1,000 mg iron) and 7.5 g PA21 (1,500 mg iron) in people with Chronic Kidney Disease, run by Vifor Pharma at 60 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in Bulgaria, Croatia, Russia, United States, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Serum-phosphate Levels at the End of Treatment. (time frame: 6 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00824460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2014.