A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
Sponsor
Vifor Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT01324128
Collaborator
Fresenius Medical Care North America (Industry)
1,059
15
3
19.1
70.6
3.7
Study Details
Study Description
Brief Summary
This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1059 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in Dialysis Patients With Hyperphosphataemia
Study Start Date
:
Mar 1, 2011
Actual Primary Completion Date
:
Apr 1, 2012
Actual Study Completion Date
:
Oct 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PA21 (2.5 g tablet)
|
Drug: PA21 (2.5 g tablet containing 500 mg iron)
Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
|
| Active Comparator: Sevelamer carbonate
|
Drug: Sevelamer carbonate
Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)
|
| Other: PA21-1 (1.25 g tablet)
|
Drug: PA21-1 (1.25 g tablet containing 250 mg iron)
Low dose comparator (1.25 g/day)
|
Outcome Measures
Primary Outcome Measures
- Change in Serum Phosphorus Levels From Week 24 to Week 27 [Week 24, Week 27]
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27
Secondary Outcome Measures
- Change in Serum Phosphorus Levels From Baseline to Week 12 [Week 12 post Baseline]
Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
-
Stable dose of phosphate binder
-
Written informed consent
Exclusion Criteria:
-
Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
-
Other significant medical conditions
-
Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Antonio | Texas | United States | 78215 | |
| 2 | LKH St. Polten | St. Polten | Austria | 3100 | |
| 3 | CHU Sart Tilman | Liege | Belgium | 4000 | |
| 4 | Clinical Hospital Center Rijeka | Rijeka | Croatia | 51000 | |
| 5 | Dialysis Centre Fresenius Medical Care | Sokolov | Czech Republic | 35601 | |
| 6 | KfH Nierenzentrum Berlin-Neukoelln | Berlin | Germany | 12045 | |
| 7 | Vidzemes Hospital | Valmiera | Latvia | LV-4201 | |
| 8 | Vilnius University Hospital Santariskiu Clinics | Vilnius | Lithuania | LT-08661 | |
| 9 | Teaching Hospital no.1 of Medical University of Lodz | Lodz | Poland | 90-153 | |
| 10 | Dialmed Clinic SRL | Sibiu | Romania | 550135 | |
| 11 | City Mariinsky Hospital | St. Petersburg | Russian Federation | 191104 | |
| 12 | Zvezdara Clinical Medical Center | Belgrade | Serbia | 11000 | |
| 13 | Lakeview Hospital | Benoni | South Africa | 1500 | |
| 14 | Mykolayiv Regional Hospital | Mykolayiv | Ukraine | 54058 | |
| 15 | Dorset County Hospital NHS Foundation Trust | Dorset | United Kingdom | DT1 2JY |
Sponsors and Collaborators
- Vifor Pharma
- Fresenius Medical Care North America
Investigators
- Principal Investigator: Juergen Floege, MD, Medizinische Klinik II
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Vifor Pharma
ClinicalTrials.gov Identifier:
NCT01324128
Other Study ID Numbers:
- PA-CL-05A
First Posted:
Mar 28, 2011
Last Update Posted:
Apr 24, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Vifor Pharma
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The first 100HD subjects that completed Stage 1 in the PA21 treatment group entered Stage 2 and were randomised to PA21 Maintenance Dose (MD) or PA21-1 Low Dose (LD). Due to a randomisation error only 99 subjects were randomised into Stage 2. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PA21 Stage 1 | Sevelamer Carbonate Stage 1 | PA21 (MD) Stage 2 | PA21-1 (LD) Stage 2 |
|---|---|---|---|---|
| Arm/Group Description | PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). | Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day). | PA21 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1 | PA21-1 (1.25 g/day) Low Dose (LD) comparator for Stage 2. |
| Period Title: Stage 1 | ||||
| STARTED | 710 | 349 | 0 | 0 |
| COMPLETED | 515 | 293 | 0 | 0 |
| NOT COMPLETED | 195 | 56 | 0 | 0 |
| Period Title: Stage 1 | ||||
| STARTED | 0 | 0 | 50 | 49 |
| COMPLETED | 0 | 0 | 42 | 46 |
| NOT COMPLETED | 0 | 0 | 8 | 3 |
Baseline Characteristics
| Arm/Group Title | PA21 Stage 1 | Sevelamer Carbonate Stage 1 | Total |
|---|---|---|---|
| Arm/Group Description | PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). | Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day). | Total of all reporting groups |
| Overall Participants | 710 | 349 | 1059 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
512
72.1%
|
242
69.3%
|
754
71.2%
|
| >=65 years |
198
27.9%
|
107
30.7%
|
305
28.8%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
56.3
(13.35)
|
55.8
(14.59)
|
56.2
(13.77)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
314
44.2%
|
129
37%
|
443
41.8%
|
| Male |
396
55.8%
|
220
63%
|
616
58.2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
345
48.6%
|
171
49%
|
516
48.7%
|
| Europe |
159
22.4%
|
77
22.1%
|
236
22.3%
|
| Russian Federation |
101
14.2%
|
50
14.3%
|
151
14.3%
|
| Ukraine |
34
4.8%
|
17
4.9%
|
51
4.8%
|
| Serbia |
47
6.6%
|
24
6.9%
|
71
6.7%
|
| Croatia |
19
2.7%
|
8
2.3%
|
27
2.5%
|
| South Africa |
5
0.7%
|
2
0.6%
|
7
0.7%
|
Outcome Measures
| Title | Change in Serum Phosphorus Levels From Week 24 to Week 27 |
|---|---|
| Description | Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27 |
| Time Frame | Week 24, Week 27 |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the Primary Outcome, data from the Primary Efficacy Set (PES) was used. The PES consists of subjects who were randomized to Stage 2 and received at least 1 dose of study medication during Stage 2 and had at least 1 post-baseline (Stage 2) efficacy assessment in Stage 2. |
| Arm/Group Title | PA21 (MD) Stage 2 | PA21-1 (LD) Stage 2 |
|---|---|---|
| Arm/Group Description | PA21 Stage 2 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1. | PA21-1 Low Dose (LD) comparator (1.25 g/day) for Stage 2 |
| Measure Participants | 44 | 49 |
| Least Squares Mean (Standard Deviation) [mg/dL] |
0.25
(0.23)
|
1.92
(0.23)
|
| Title | Change in Serum Phosphorus Levels From Baseline to Week 12 |
|---|---|
| Description | Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group. |
| Time Frame | Week 12 post Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the Secondary Outcome, data from the Per Protocol Set (PPS) was used. The PPS consists of all subjects who had completed the analysis dose titration period (baseline to Week 12), had at least 1 evaluable serum phosphorus result at or after Week 12, and had no major protocol deviations. |
| Arm/Group Title | PA21 (2.5 g Tablet) Stage 1 | Sevelamer Carbonate Stage 1 |
|---|---|---|
| Arm/Group Description | PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). | Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day). |
| Measure Participants | 461 | 224 |
| Least Squares Mean (Standard Error) [mg/dL] |
-2.19
(0.09)
|
-2.45
(0.11)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment. | |||||||
| Arm/Group Title | PA21 Stage 1 | Sevelamer Carbonate Stage 1 | PA21-1 (LD) Stage 2 | PA21 (MD) Stage 2 | ||||
| Arm/Group Description | PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day). | Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day). | PA21-1 (1.25 g tablet). Low Dose (LD) comparator (1.25 g/day) for Stage 2. | PA21 (2.5g tablet) Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1. | ||||
All Cause Mortality |
||||||||
| PA21 Stage 1 | Sevelamer Carbonate Stage 1 | PA21-1 (LD) Stage 2 | PA21 (MD) Stage 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| PA21 Stage 1 | Sevelamer Carbonate Stage 1 | PA21-1 (LD) Stage 2 | PA21 (MD) Stage 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 129/707 (18.2%) | 69/348 (19.8%) | 6/49 (12.2%) | 2/45 (4.4%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/707 (0.1%) | 1 | 3/348 (0.9%) | 3 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Thrombocytopenia | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac disorders | ||||||||
| Acute left ventricular failure | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Acute myocardial infarction | 9/707 (1.3%) | 9 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Angina pectoris | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Angina unstable | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Aortic valve stenosis | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Atrial fibrillation | 2/707 (0.3%) | 2 | 2/348 (0.6%) | 2 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Atrial flutter | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Atrioventricular block complete | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Bradycardia | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac arrest | 3/707 (0.4%) | 3 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac failure | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac failure acute | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiac tamponade | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cardio-respiratory arrest | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiogenic shock | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cardiopulmonary failure | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Congestive cardiac failure | 6/707 (0.8%) | 6 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Congestive cardiomyopathy | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Coronary artery disease | 2/707 (0.3%) | 2 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Coronary artery stenosis | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Myocardial infarction | 2/707 (0.3%) | 2 | 3/348 (0.9%) | 3 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Myocardial ischaemia | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pericardial effusion | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Ventricular extrasystoles | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Ventricular tachycardia | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Acute coronary syndrome | 0/707 (0%) | 0 | 0/348 (0%) | 0 | 1/49 (2%) | 1 | 0/45 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||
| Arteriovenous malformation | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Vertigo | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Endocrine disorders | ||||||||
| Thyroiditis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Eye disorders | ||||||||
| Diabetic eye disease | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Vitreous haemorrhage | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal hernia obstructive | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Abdominal pain | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Abdominal wall haematoma | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Diarrhoea | 2/707 (0.3%) | 2 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Duodenal ulcer haemorrhage | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Duodenitis haemorrhagic | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Faeces discoloured | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Gastritis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Gastrointestinal haemorrhage | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Gastrointestinal necrosis | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Oesophageal ulcer | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pancreatitis acute | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pancreatitis chronic | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Peritonitis | 4/707 (0.6%) | 4 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Umbilical hernia | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Umbilical hernia, obstructive | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Vomiting | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| General disorders | ||||||||
| Chest pain | 8/707 (1.1%) | 9 | 5/348 (1.4%) | 6 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Death | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Medical device complications | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 1/45 (2.2%) | 1 |
| Non-cardiac chest pain | 1/707 (0.1%) | 1 | 2/348 (0.6%) | 2 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pyrexia | 1/707 (0.1%) | 2 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Thrombosis in device | 0/707 (0%) | 0 | 2/348 (0.6%) | 2 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Systemic inflammatory response syndrome | 0/707 (0%) | 0 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 1/45 (2.2%) | 1 |
| Hepatobiliary disorders | ||||||||
| Biliary dyskinesia | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cholecystitis | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cholecystitis acute | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Infections and infestations | ||||||||
| Abscess limb | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Acute tonsillitis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Appendicitis | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arteriovenous fistula site infection | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arteriovenous graft site infection | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Bacteraemia | 2/707 (0.3%) | 2 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Bacterial sepsis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Bactiuria | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Bronchitis | 4/707 (0.6%) | 4 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Bronchopneumonia | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cellulitis | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Clostridial infection | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Clostridium difficile colitis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Device related infection | 0/707 (0%) | 0 | 2/348 (0.6%) | 2 | 1/49 (2%) | 1 | 0/45 (0%) | 0 |
| Endocarditis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Enterococcal bacteraemia | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Escherichia bacteraemia | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Escherichia sepsis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Gangrene | 1/707 (0.1%) | 1 | 2/348 (0.6%) | 2 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Gastroenteritis | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Gastroenteritis viral | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Graft infection | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Groin abscess | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hepatic cyst infection | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Necrotising fasciitis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Osteomyelitis | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 1/49 (2%) | 1 | 0/45 (0%) | 0 |
| Pneumonia viral | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Peritonitis bacterial | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pneumonia | 7/707 (1%) | 7 | 2/348 (0.6%) | 2 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Renal cyst infection | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Sepsis | 4/707 (0.6%) | 5 | 3/348 (0.9%) | 3 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Sepsis syndrome | 3/707 (0.4%) | 3 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Shunt infection | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Staphylococcal bacteraemia | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Staphylococcal sepsis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Subcutaneous abscess | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Urinary tract infection | 2/707 (0.3%) | 2 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Accidental overdose | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Ankle fracture | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arteriovenous fistula aneurysm | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arteriovenous fistula site complication | 0/707 (0%) | 0 | 2/348 (0.6%) | 2 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arteriovenous fistula site haemorrhage | 3/707 (0.4%) | 3 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arteriovenous fistula thrombosis | 3/707 (0.4%) | 3 | 2/348 (0.6%) | 2 | 1/49 (2%) | 1 | 0/45 (0%) | 0 |
| Arteriovenous graft site haemorrhage | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Contusion | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Fall | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Femur fracture | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pelvic fracture | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Post concussion syndrome | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Rib fracture | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Shunt occlusion | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Shunt stenosis | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Shunt thrombosis | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Tibia fracture | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Traumatic brain injury | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Vascular access complication | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Vascular graft thrombosis | 3/707 (0.4%) | 4 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Vascular pseudoaneurysm | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Wound complication | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Wrist fracture | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Investigations | ||||||||
| Blood glucose abnormal | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Catheterisation cardiac | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Haemoglobin decreased | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| International normalised ratio decreased | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| International normalised ratio increased | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Calciphylaxis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Diabetic ketoacidosis | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Fluid overload | 4/707 (0.6%) | 4 | 4/348 (1.1%) | 4 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hyperkalaemia | 3/707 (0.4%) | 4 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hypoglycaemia | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Type 1 diabetes mellitus | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Joint swelling | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Myalgia | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Systemic lupus erythematosus | 0/707 (0%) | 0 | 2/348 (0.6%) | 2 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pain in extremity | 0/707 (0%) | 0 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 1/45 (2.2%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Myelofibrosis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Prostate cancer recurrent | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Prostatic adenoma | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Renal cell carcinoma | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Nervous system disorders | ||||||||
| Cerebral haemorrhage | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cerebrovascular accident | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Cervicobrachial syndrome | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Dementia | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Dizziness | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Dysarthria | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Embolic stroke | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Headache | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hypertensive encephalopathy | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Syncope | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Transient ischaemic attack | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Toxic encelphalopathy | 0/707 (0%) | 0 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 1/45 (2.2%) | 1 |
| Mental impairment | 0/707 (0%) | 0 | 0/348 (0%) | 0 | 1/49 (2%) | 1 | 0/45 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Bipolar disorder | 1/707 (0.1%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Haemorrhage urinary tract | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Renal failure chronic | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Renal tubular necrosis | 0/707 (0%) | 0 | 0/348 (0%) | 0 | 1/49 (2%) | 1 | 0/45 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Acute pulmonary oedema | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Acute respiratory failure | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Chronic obstructive pulmonary disease | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Dyspnoea | 4/707 (0.6%) | 4 | 4/348 (1.1%) | 4 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Haemoptysis | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hypoxia | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pleural effusion | 3/707 (0.4%) | 3 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pneumonia aspiration | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pulmonary embolism | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Pulmonary oedema | 3/707 (0.4%) | 3 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Respiratory failure | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis allergic | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Diabetic ulcer | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 1/49 (2%) | 1 | 0/45 (0%) | 0 |
| Skin ulcer | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Surgical and medical procedures | ||||||||
| Angioplasty | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arteriovenous fistula operation | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arteriovenous graft | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Ateriovenous shunt operation | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Nephrectomy | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Renal transplant | 1/707 (0.1%) | 1 | 1/348 (0.3%) | 1 | 1/49 (2%) | 1 | 0/45 (0%) | 0 |
| Vascular disorders | ||||||||
| Aneurysm | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Aortic stenosis | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Arterial thrombosis limb | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Bleeding varicose vein | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Deep vein thrombosis | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Haemorrhage | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hypertension | 6/707 (0.8%) | 6 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hypertensive crisis | 2/707 (0.3%) | 2 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hypertensive emergency | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Hypotension | 3/707 (0.4%) | 3 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Leriche syndrome | 1/707 (0.1%) | 1 | 0/348 (0%) | 0 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Peripheral ischaemia | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Peripheral vascular disorder | 1/707 (0.1%) | 1 | 3/348 (0.9%) | 3 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Shock haemorrhagic | 0/707 (0%) | 0 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| PA21 Stage 1 | Sevelamer Carbonate Stage 1 | PA21-1 (LD) Stage 2 | PA21 (MD) Stage 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 426/707 (60.3%) | 162/348 (46.6%) | 10/49 (20.4%) | 2/45 (4.4%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 142/707 (20.1%) | 184 | 26/348 (7.5%) | 31 | 1/49 (2%) | 1 | 1/45 (2.2%) | 1 |
| Faeces discoloured | 109/707 (15.4%) | 110 | 1/348 (0.3%) | 1 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Nausea | 51/707 (7.2%) | 60 | 39/348 (11.2%) | 41 | 0/49 (0%) | 0 | 1/45 (2.2%) | 1 |
| Vomiting | 31/707 (4.4%) | 36 | 19/348 (5.5%) | 22 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Constipation | 27/707 (3.8%) | 33 | 25/348 (7.2%) | 26 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Hyperphosphataemia | 79/707 (11.2%) | 114 | 27/348 (7.8%) | 39 | 7/49 (14.3%) | 7 | 0/45 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 23/707 (3.3%) | 25 | 7/348 (2%) | 7 | 3/49 (6.1%) | 3 | 0/45 (0%) | 0 |
| Vascular disorders | ||||||||
| Hypertension | 45/707 (6.4%) | 54 | 26/348 (7.5%) | 39 | 0/49 (0%) | 0 | 0/45 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Investigators may not present or publish partial or complete study results individually. Any manuscript or abstract proposed by the Investigators must be reviewed and approved in writing by Vifor Pharma before submission for publication. Names of all Investigators participating in the study will be included in the publication.
Results Point of Contact
| Name/Title | Medical Information |
|---|---|
| Organization | Vifor Pharma |
| Phone | 41 58 851 8222 |
| medinfo@viforpharma.com |
Responsible Party:
Vifor Pharma
ClinicalTrials.gov Identifier:
NCT01324128
Other Study ID Numbers:
- PA-CL-05A
First Posted:
Mar 28, 2011
Last Update Posted:
Apr 24, 2014
Last Verified:
Apr 1, 2014