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Trial record 1 of 1 for:    DRI12793
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An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01574326
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Hyperphosphatemia
Chronic Kidney Disease
Interventions Drug: Placebo
Drug: Sevelamer carbonate
Enrollment 101
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 Details 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
Hide 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
Reason Not Completed
Randomized but not treated             0             1
Withdrawal by Participant             2             4
Physician Decision             5             3
Adverse Event             1             3
Other: Mainly kidney transplant             8             8
Arm/Group Title FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate Total
Hide 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 Number of Baseline Participants 51 50 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 50 participants 101 participants
14.3  (3.11) 13.9  (2.75) 14.1  (2.93)
[1]
Measure Description: Age continuous is reported here for safety set: N= 51 and N=49 for 'FDP-Placebo for sevelamer carbonate, DTP-Sevelamer carbonate' and 'FDP-Sevelamer carbonate, DTP-Sevelamer carbonate' arms respectively. All enrolled participants who were treated with at least 1 dose of study drug were included in the safety set.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 101 participants
Female
18
  35.3%
19
  38.0%
37
  36.6%
Male
33
  64.7%
31
  62.0%
64
  63.4%
1.Primary Outcome
Title Change From Baseline (Week 0) to Week 2 in Serum Phosphorus
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 49 48
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
2.Primary Outcome
Title Treatment – Emergent Adverse Events (AEs)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 51 49
Measure Type: Number
Unit of Measure: participants
Any AE: FDP 20 19
AE related: FDP 3 2
Any SAE: FDP 1 4
SAE related: FDP 0 0
Any AE Leading to Study Drug Discontinuation: FDP 1 1
Any AE: DTP 42 35
AE related: DTP 9 4
Any SAE: DTP 14 17
SAE related: DTP 2 2
Any AE Leading to Study Drug Discontinuation: DTP 0 3
Deaths 0 0
3.Secondary Outcome
Title Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 49 46
Mean (Standard Deviation)
Unit of Measure: mg/dL
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)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FDP - Placebo FDP - Sevelamer Carbonate DTP - Sevelamer Carbonate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/51 (1.96%)   4/49 (8.16%)   31/100 (31.00%) 
Blood and lymphatic system disorders       
Anaemia  1  0/51 (0.00%)  0/49 (0.00%)  2/100 (2.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/51 (0.00%)  0/49 (0.00%)  3/100 (3.00%) 
Constipation  1  0/51 (0.00%)  0/49 (0.00%)  2/100 (2.00%) 
Diarrhoea  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Gastritis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Vomiting  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
General disorders       
Device dislocation  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Device malfunction  1  0/51 (0.00%)  0/49 (0.00%)  2/100 (2.00%) 
Device occlusion  1  0/51 (0.00%)  1/49 (2.04%)  1/100 (1.00%) 
Extravasation  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Fatigue  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Non-cardiac chest pain  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Pyrexia  1  0/51 (0.00%)  0/49 (0.00%)  3/100 (3.00%) 
Immune system disorders       
Anti-neutrophil cytoplasmic antibody positive vasculitis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Kidney transplant rejection  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Infections and infestations       
Bacteraemia  1  0/51 (0.00%)  0/49 (0.00%)  2/100 (2.00%) 
Catheter site infection  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Fungal peritonitis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Gastroenteritis viral  1  1/51 (1.96%)  0/49 (0.00%)  0/100 (0.00%) 
Pelvic inflammatory disease  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Peritonitis  1  0/51 (0.00%)  1/49 (2.04%)  2/100 (2.00%) 
Peritonitis bacterial  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Pharyngitis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Pneumonia  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Septic shock  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Upper respiratory tract infection  1  0/51 (0.00%)  0/49 (0.00%)  2/100 (2.00%) 
Urinary tract infection  1  0/51 (0.00%)  0/49 (0.00%)  2/100 (2.00%) 
Urosepsis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Vaginitis chlamydial  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Varicella zoster virus infection  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Viral infection  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Injury, poisoning and procedural complications       
Arteriovenous fistula site complication  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Arteriovenous fistula thrombosis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Laceration  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Post procedural constipation  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Shunt occlusion  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Investigations       
Blood creatinine increased  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Metabolism and nutrition disorders       
Fluid overload  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Hyperkalaemia  1  0/51 (0.00%)  1/49 (2.04%)  2/100 (2.00%) 
Hyperphosphataemia  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Hypocalcaemia  1  0/51 (0.00%)  0/49 (0.00%)  2/100 (2.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Flank pain  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Nervous system disorders       
Hypoxic-ischaemic encephalopathy  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Psychiatric disorders       
Mental status changes  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Renal and urinary disorders       
Focal segmental glomerulosclerosis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Oliguria  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Renal failure  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Renal impairment  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Dyspnoea  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Hypoxia  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Pulmonary embolism  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Vascular disorders       
Hypertension  1  0/51 (0.00%)  2/49 (4.08%)  1/100 (1.00%) 
Hypertensive crisis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Hypotension  1  0/51 (0.00%)  0/49 (0.00%)  2/100 (2.00%) 
Orthostatic hypotension  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Vena cava thrombosis  1  0/51 (0.00%)  0/49 (0.00%)  1/100 (1.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 18
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FDP - Placebo FDP - Sevelamer Carbonate DTP - Sevelamer Carbonate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/51 (11.76%)   7/49 (14.29%)   57/100 (57.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/51 (0.00%)  1/49 (2.04%)  13/100 (13.00%) 
Abdominal pain upper  1  2/51 (3.92%)  0/49 (0.00%)  9/100 (9.00%) 
Diarrhoea  1  0/51 (0.00%)  1/49 (2.04%)  8/100 (8.00%) 
Nausea  1  2/51 (3.92%)  0/49 (0.00%)  15/100 (15.00%) 
Vomiting  1  3/51 (5.88%)  0/49 (0.00%)  19/100 (19.00%) 
General disorders       
Catheter site pain  1  0/51 (0.00%)  0/49 (0.00%)  6/100 (6.00%) 
Pyrexia  1  0/51 (0.00%)  1/49 (2.04%)  16/100 (16.00%) 
Immune system disorders       
Seasonal allergy  1  0/51 (0.00%)  0/49 (0.00%)  6/100 (6.00%) 
Infections and infestations       
Nasopharyngitis  1  0/51 (0.00%)  0/49 (0.00%)  6/100 (6.00%) 
Upper respiratory tract infection  1  0/51 (0.00%)  0/49 (0.00%)  10/100 (10.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  0/51 (0.00%)  1/49 (2.04%)  8/100 (8.00%) 
Nervous system disorders       
Dizziness  1  0/51 (0.00%)  1/49 (2.04%)  7/100 (7.00%) 
Headache  1  2/51 (3.92%)  2/49 (4.08%)  17/100 (17.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/51 (0.00%)  0/49 (0.00%)  7/100 (7.00%) 
Vascular disorders       
Hypertension  1  0/51 (0.00%)  1/49 (2.04%)  7/100 (7.00%) 
Hypotension  1  1/51 (1.96%)  0/49 (0.00%)  8/100 (8.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 18
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Genzyme Corporation
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01574326     History of Changes
Other Study ID Numbers: SVCARB07609
2011-002329-23 ( EudraCT Number )
DRI12793 ( Other Identifier: Genzyme Corporation )
First Submitted: April 6, 2012
First Posted: April 10, 2012
Results First Submitted: June 14, 2016
Results First Posted: July 25, 2016
Last Update Posted: July 25, 2016