An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

• Sponsor: Genzyme, a Sanofi Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01574326
• Collaborator: (none)
• Enrollment: 101
• Locations: 32
• Arms: 2
• Duration (Months): 37
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to

• Evaluate the safety and tolerability of sevelamer carbonate

• Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia; Chronic Kidney Disease	Drug: Placebo; Drug: Sevelamer carbonate	Phase 2

Detailed Description

The study was divided into 3 periods: a phosphate binder washout Period; a randomized, double-blind, placebo-controlled, Fixed Dose Period; and an open-label, sevelamer carbonate Dose Titration Period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP).	Drug: Placebo; Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets; Drug: Sevelamer carbonate; 0.8 g sachets of powder for oral suspension or 800 mg tablets; Other Names: Renvela®
Experimental: FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP.	Drug: Placebo; Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets; Drug: Sevelamer carbonate; 0.8 g sachets of powder for oral suspension or 800 mg tablets; Other Names: Renvela®

Outcome Measures

Primary Outcome Measures

1. Change From Baseline (Week 0) to Week 2 in Serum Phosphorus [Baseline, Week 2]

   Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.

2. Treatment - Emergent Adverse Events (AEs) [Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)]

   A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.

Secondary Outcome Measures

1. Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus [Baseline, Week 28/Early Termination]

   Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The participant had CKD requiring dialysis or CKD not on dialysis with an estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m^2 based on central laboratory results.

• The participant had a serum phosphorus level greater than the age appropriate upper limit of normal based on central laboratory results.

Exclusion Criteria:

• The participant had active dysphagia, swallowing disorders or a predisposition to or current bowel obstruction, ileus or severe gastrointestinal motility disorder(s) including severe constipation, or major gastrointestinal tract surgery.

• The participant had a non-renal case of hyperphosphatemia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site Number 8003	Birmingham	Alabama	United States	35205
2	Investigational Site Number 8005	Birmingham	Alabama	United States	35205
3	Investigational Site Number 8013	Los Angeles	California	United States	90024
4	Investigational Site Number 8014	San Francisco	California	United States	94143
5	Investigational Site Number 8025	Orlando	Florida	United States	32806
6	Investigational Site Number 8007	Atlanta	Georgia	United States	30322
7	Investigational Site Number 8019	Iowa City	Iowa	United States
8	Investigational Site Number 8012	Baltimore	Maryland	United States	21287
9	Investigational Site Number 8008	Boston	Massachusetts	United States	02115
10	Investigational Site Number 8020	Detroit	Michigan	United States	48201
11	Investigational Site Number 8022	Kansas City	Missouri	United States	64108
12	Investigational Site Number 8023	St Louis	Missouri	United States	63110
13	Investigational Site Number 8017	Livingston	New Jersey	United States	07039
14	Investigational Site Number 8018	Buffalo	New York	United States	14222
15	Investigational Site Number 8009	Greenville	North Carolina	United States	27834
16	Investigational Site Number 8010	Portland	Oregon	United States	97201-3098
17	Investigational Site Number 8011	Philadelphia	Pennsylvania	United States	19104
18	Investigational Site Number 8026	Dallas	Texas	United States	75390
19	Investigational Site Number 8016	Houston	Texas	United States	77030
20	Investigational Site Number 8001	San Antonio	Texas	United States	78229
21	Investigational Site Number 8002	Charlottesville	Virginia	United States	22908
22	Investigational Site Number 8027	Richmond	Virginia	United States	23298-0034
23	Investigational Site Number 8006	Seattle	Washington	United States	98105
24	Investigational Site Number 8101	Bordeaux		France	33076
25	Investigational Site Number 8102	Bron		France	69677
26	Investigational Site Number 8103	Paris Cedex 19		France	75935
27	Investigational Site Number 8201	Berlin		Germany	13353
28	Investigational Site Number 8202	Marburg		Germany	35033
29	Investigational Site Number 8302	Kaunas		Lithuania	50009
30	Investigational Site Number 8301	Vilnius		Lithuania	08406
31	Investigational Site Number 8402	Gdansk		Poland
32	Investigational Site Number 8401	Krakow		Poland	301-663

Sponsors and Collaborators

• Genzyme, a Sanofi Company

Investigators

• Study Director: Medical Monitor, Genzyme, a Sanofi Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genzyme, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT01574326
• Other Study ID Numbers: SVCARB07609; 2011-002329-23; DRI12793
• First Posted: Apr 10, 2012
• Last Update Posted: Jul 25, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Genzyme, a Sanofi Company: Chronic Kidney Disease; Pediatric; Sevelamer Carbonate; Hyperphosphatemia
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia; Sevelamer

Study Results

Participant Flow

Recruitment Details	The study was conducted at 29 centers in 4 countries. A total of 128 participants were screened between 11 May 2012 and 14 November 2014. Of whom, 101 participants were randomized and 27 were screen failures.
Pre-assignment Detail	Participants were stratified in (1:1) by screening body surface area (BSA) (≥1.2 vs <1.2 m^2) & qualifying serum phosphorus (≥7.0 vs <7.0 mg/dL) to get sevelamer carbonate or placebo in 2 week fixed dose period (FDP). Following FDP, participants entered 26-week dose titration period (DTP) during which all participants received sevelamer carbonate.

Arm/Group Title	FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate	FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Arm/Group Description	Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate 3 times a day (TID) for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as powder for oral suspension (POS) & 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
Period Title: Overall Study
STARTED	51	50
Treated	51	49
COMPLETED	35	31
NOT COMPLETED	16	19

Baseline Characteristics

Arm/Group Title	FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate	FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate	Total
Arm/Group Description	Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate TID for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 POS and 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).	Total of all reporting groups
Overall Participants	51	50	101
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	14.3 (3.11)	13.9 (2.75)	14.1 (2.93)
Sex: Female, Male (Count of Participants)
Female	18 35.3%	19 38%	37 36.6%
Male	33 64.7%	31 62%	64 63.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
Description	Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

FAS-FDP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline assessment after the first dose of study drug and on or before Week 2. Three participants (1 in sevelamer carbonate group and 2 in placebo group) were excluded from FAS-FDP due to no baseline phosphorus value at week 2.

Arm/Group Title	FDP-Placebo for Sevelamer Carbonate	FDP-Sevelamer Carbonate
Arm/Group Description	Participants received placebo for sevelamer carbonate for first 2 weeks in FDP.	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP.
Measure Participants	49	48
At Baseline	7.2 (1.841)	7.2 (2.09)
At Week 2	7.24 (2.029)	6.34 (1.306)
Change from baseline to Week 2	0.04 (1.478)	-0.87 (1.649)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FDP-Placebo for Sevelamer Carbonate, FDP-Sevelamer Carbonate
	Comments	Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments	Threshold for significance ≤ 0.05.
Method of Estimation	Estimation Parameter	Least square (LS) mean difference
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -1.44 to -0.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Treatment - Emergent Adverse Events (AEs)
Description	A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.
Time Frame	Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)

Outcome Measure Data

Analysis Population Description

Analysis was performed on safety set, which included all enrolled participants who received at least 1 dose of study drug. Participants were analyzed according to actual received treatment.

Arm/Group Title	FDP- Placebo for Sevelamer Carbonate; DTP- Sevelamer Carbonate	FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Arm/Group Description	Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter, participants received sevelamer carbonate for 26 weeks in DTP.	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP based on the screening BSA category.
Measure Participants	51	49
Any AE: FDP	20 39.2%	19 38%
AE related: FDP	3 5.9%	2 4%
Any SAE: FDP	1 2%	4 8%
SAE related: FDP	0 0%	0 0%
Any AE Leading to Study Drug Discontinuation: FDP	1 2%	1 2%
Any AE: DTP	42 82.4%	35 70%
AE related: DTP	9 17.6%	4 8%
Any SAE: DTP	14 27.5%	17 34%
SAE related: DTP	2 3.9%	2 4%
Any AE Leading to Study Drug Discontinuation: DTP	0 0%	3 6%
Deaths	0 0%	0 0%

3. Secondary Outcome

Title	Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus
Description	Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.
Time Frame	Baseline, Week 28/Early Termination

Outcome Measure Data

Analysis Population Description

FAS-DTP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline phosphorus assessment after Week 2. Five participants (3 in sevelamer carbonate group and 2 in the placebo group) were excluded from the FAS-DTP due to no baseline phosphorus value or no phosphorus assessment after Week 2.

Arm/Group Title	FDP- Placebo for Sevelamer Carbonate; DTP- Sevelamer Carbonate	FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate
Arm/Group Description	Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter participants received sevelamer carbonate for 26 weeks in DTP.	Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP.
Measure Participants	49	46
At Baseline (Week 0)	7.05 (1.797)	7.28 (2.103)
At Week 28 / Early Termination	5.92 (1.612)	6.04 (1.878)
Change from Baseline to Week 28/Early Termination	-1.13 (2.061)	-1.23 (2.206)

Adverse Events

Time Frame	All AEs were collected from signature of informed consent form up to final visit regardless of seriousness or relationship to investigational product. SAEs occurring during 15 days following study completion or early termination were also to be collected.
Adverse Event Reporting Description	Reported AEs are treatment emergent adverse events (includes non-serious AEs and SAEs as applicable) that is AE that developed/worsened during the 'on treatment period' (from the first dose of study drug up to end of study period). Analysis was performed on safety set.
Arm/Group Title	FDP - Placebo		FDP - Sevelamer Carbonate		DTP - Sevelamer Carbonate
Arm/Group Description	Participants exposed to placebo (for sevelamer carbonate) for first 2 weeks in FDP (median exposure of 15 days).		Participants exposed to sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for first 2 weeks in FDP (median exposure of 15 days).		Participants who received placebo and participants who received sevelamer carbonate in FDP received sevelamer carbonate for 26 weeks in DTP (median exposure of 183.5 days in participants who were on sevelamer carbonate in FDP and 183 days in participants who were on placebo in FDP).
All Cause Mortality
	FDP - Placebo		FDP - Sevelamer Carbonate		DTP - Sevelamer Carbonate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	FDP - Placebo		FDP - Sevelamer Carbonate		DTP - Sevelamer Carbonate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/51 (2%)		4/49 (8.2%)		31/100 (31%)
Blood and lymphatic system disorders
Anaemia	0/51 (0%)		0/49 (0%)		2/100 (2%)
Gastrointestinal disorders
Abdominal pain	0/51 (0%)		0/49 (0%)		3/100 (3%)
Constipation	0/51 (0%)		0/49 (0%)		2/100 (2%)
Diarrhoea	0/51 (0%)		0/49 (0%)		1/100 (1%)
Gastritis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Vomiting	0/51 (0%)		0/49 (0%)		1/100 (1%)
General disorders
Device dislocation	0/51 (0%)		0/49 (0%)		1/100 (1%)
Device malfunction	0/51 (0%)		0/49 (0%)		2/100 (2%)
Device occlusion	0/51 (0%)		1/49 (2%)		1/100 (1%)
Extravasation	0/51 (0%)		0/49 (0%)		1/100 (1%)
Fatigue	0/51 (0%)		0/49 (0%)		1/100 (1%)
Non-cardiac chest pain	0/51 (0%)		0/49 (0%)		1/100 (1%)
Pyrexia	0/51 (0%)		0/49 (0%)		3/100 (3%)
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Kidney transplant rejection	0/51 (0%)		0/49 (0%)		1/100 (1%)
Infections and infestations
Bacteraemia	0/51 (0%)		0/49 (0%)		2/100 (2%)
Catheter site infection	0/51 (0%)		0/49 (0%)		1/100 (1%)
Fungal peritonitis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Gastroenteritis viral	1/51 (2%)		0/49 (0%)		0/100 (0%)
Pelvic inflammatory disease	0/51 (0%)		0/49 (0%)		1/100 (1%)
Peritonitis	0/51 (0%)		1/49 (2%)		2/100 (2%)
Peritonitis bacterial	0/51 (0%)		0/49 (0%)		1/100 (1%)
Pharyngitis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Pneumonia	0/51 (0%)		0/49 (0%)		1/100 (1%)
Septic shock	0/51 (0%)		0/49 (0%)		1/100 (1%)
Upper respiratory tract infection	0/51 (0%)		0/49 (0%)		2/100 (2%)
Urinary tract infection	0/51 (0%)		0/49 (0%)		2/100 (2%)
Urosepsis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Vaginitis chlamydial	0/51 (0%)		0/49 (0%)		1/100 (1%)
Varicella zoster virus infection	0/51 (0%)		0/49 (0%)		1/100 (1%)
Viral infection	0/51 (0%)		0/49 (0%)		1/100 (1%)
Injury, poisoning and procedural complications
Arteriovenous fistula site complication	0/51 (0%)		0/49 (0%)		1/100 (1%)
Arteriovenous fistula thrombosis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Laceration	0/51 (0%)		0/49 (0%)		1/100 (1%)
Post procedural constipation	0/51 (0%)		0/49 (0%)		1/100 (1%)
Shunt occlusion	0/51 (0%)		0/49 (0%)		1/100 (1%)
Investigations
Blood creatinine increased	0/51 (0%)		0/49 (0%)		1/100 (1%)
Metabolism and nutrition disorders
Fluid overload	0/51 (0%)		0/49 (0%)		1/100 (1%)
Hyperkalaemia	0/51 (0%)		1/49 (2%)		2/100 (2%)
Hyperphosphataemia	0/51 (0%)		0/49 (0%)		1/100 (1%)
Hypocalcaemia	0/51 (0%)		0/49 (0%)		2/100 (2%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/51 (0%)		0/49 (0%)		1/100 (1%)
Flank pain	0/51 (0%)		0/49 (0%)		1/100 (1%)
Nervous system disorders
Hypoxic-ischaemic encephalopathy	0/51 (0%)		0/49 (0%)		1/100 (1%)
Psychiatric disorders
Mental status changes	0/51 (0%)		0/49 (0%)		1/100 (1%)
Renal and urinary disorders
Focal segmental glomerulosclerosis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Oliguria	0/51 (0%)		0/49 (0%)		1/100 (1%)
Renal failure	0/51 (0%)		0/49 (0%)		1/100 (1%)
Renal impairment	0/51 (0%)		0/49 (0%)		1/100 (1%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/51 (0%)		0/49 (0%)		1/100 (1%)
Dyspnoea	0/51 (0%)		0/49 (0%)		1/100 (1%)
Hypoxia	0/51 (0%)		0/49 (0%)		1/100 (1%)
Pulmonary embolism	0/51 (0%)		0/49 (0%)		1/100 (1%)
Vascular disorders
Hypertension	0/51 (0%)		2/49 (4.1%)		1/100 (1%)
Hypertensive crisis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Hypotension	0/51 (0%)		0/49 (0%)		2/100 (2%)
Orthostatic hypotension	0/51 (0%)		0/49 (0%)		1/100 (1%)
Vena cava thrombosis	0/51 (0%)		0/49 (0%)		1/100 (1%)
Other (Not Including Serious) Adverse Events
	FDP - Placebo		FDP - Sevelamer Carbonate		DTP - Sevelamer Carbonate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/51 (11.8%)		7/49 (14.3%)		57/100 (57%)
Gastrointestinal disorders
Abdominal pain	0/51 (0%)		1/49 (2%)		13/100 (13%)
Abdominal pain upper	2/51 (3.9%)		0/49 (0%)		9/100 (9%)
Diarrhoea	0/51 (0%)		1/49 (2%)		8/100 (8%)
Nausea	2/51 (3.9%)		0/49 (0%)		15/100 (15%)
Vomiting	3/51 (5.9%)		0/49 (0%)		19/100 (19%)
General disorders
Catheter site pain	0/51 (0%)		0/49 (0%)		6/100 (6%)
Pyrexia	0/51 (0%)		1/49 (2%)		16/100 (16%)
Immune system disorders
Seasonal allergy	0/51 (0%)		0/49 (0%)		6/100 (6%)
Infections and infestations
Nasopharyngitis	0/51 (0%)		0/49 (0%)		6/100 (6%)
Upper respiratory tract infection	0/51 (0%)		0/49 (0%)		10/100 (10%)
Musculoskeletal and connective tissue disorders
Pain in extremity	0/51 (0%)		1/49 (2%)		8/100 (8%)
Nervous system disorders
Dizziness	0/51 (0%)		1/49 (2%)		7/100 (7%)
Headache	2/51 (3.9%)		2/49 (4.1%)		17/100 (17%)
Respiratory, thoracic and mediastinal disorders
Cough	0/51 (0%)		0/49 (0%)		7/100 (7%)
Vascular disorders
Hypertension	0/51 (0%)		1/49 (2%)		7/100 (7%)
Hypotension	1/51 (2%)		0/49 (0%)		8/100 (8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.