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Clinical trials for Sevelamer Carbonate (Renvela)

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    10 result(s) found for: Sevelamer Carbonate (Renvela). Displaying page 1 of 1.
    EudraCT Number: 2011-006320-20 Sponsor Protocol Number: CT.SVL.PD.10.001 Start Date*: 2012-05-17
    Sponsor Name:Synthon BV
    Full Title: A multicenter, randomized, double-blind, multiple dose, crossover study to evaluate the safety and equivalence of serum phosphate control of a new sevelamer carbonate tablet formulation in compari...
    Medical condition: Evaluation of the safety and equivalence of serum phosphate control of a sevelamer carbonate tablet formulation in comparison with Renvela® in chronic kidney disease patients on hemodialysis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10020712 Hyperphosphatemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-020415-36 Sponsor Protocol Number: SUS2010GOLA01 Start Date*: 2010-07-15
    Sponsor Name:Stavanger University Hospital
    Full Title: En åpen, randomisert cross over studie av fosfatbinder (sevelamer) eller aktivt vitamin D hos pasienter med kronisk nyresvikt i stadium 3b (eGFR 30-45 ml/min/1,73 m2) for evaluering av fibroblast l...
    Medical condition: Chronic renal failure, stage 3B.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005416-26 Sponsor Protocol Number: ANSWER Start Date*: 2014-06-06
    Sponsor Name:Mario Negri Institute
    Full Title: A Prospective, Randomized, Open, Blinded Endpoint (PROBE), Clinical Trial to Assess The Renal and Humoral Effects of Sevelamer Carbonate in Patients with Chronic Kidney Disease and Residual Protein...
    Medical condition: Chronic Kidney Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002329-23 Sponsor Protocol Number: SVCARB07609 Start Date*: 2013-06-20
    Sponsor Name:Genzyme Corporation and its Affiliates
    Full 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 ...
    Medical condition: Treatment of hyperphosphataemia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004857 10064848 Chronic kidney disease LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-001772-22 Sponsor Protocol Number: 96HCL15_0122 Start Date*: 2016-01-25
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Mesures des modifications hémodynamiques, fonctionnelles et métaboliques rénales par TEP et BOLD- IRM en lien avec la modification des apports en AGE dans l’alimentation, ou avec sevelamer. ETUDE A...
    Medical condition: Volontaires sains
    Disease: Version SOC Term Classification Code Term Level
    18.1 10022891 - Investigations 10058910 General physical condition normal PT
    Population Age: Adults Gender: Male
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022011-19 Sponsor Protocol Number: PA-CL-05A Start Date*: 2011-02-21
    Sponsor Name:Vifor (International) Inc.
    Full 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 Co...
    Medical condition: Control of hyperphosphataemia in patients with chronic kidney disease on dialysis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease LLT
    14.0 10027433 - Metabolism and nutrition disorders 10020711 Hyperphosphataemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) LV (Completed) LT (Completed) SE (Completed) AT (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022012-40 Sponsor Protocol Number: PA-CL-05B Start Date*: 2011-02-21
    Sponsor Name:Vifor (International) Inc.
    Full Title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Phase 3 Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21 compared with Sevelamer Carbonate in D...
    Medical condition: Control of hyperphosphataemia in patients with chronic kidney disease on dialysis
    Disease: Version SOC Term Classification Code Term Level
    15.0 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease LLT
    15.0 10027433 - Metabolism and nutrition disorders 10020712 Hyperphosphatemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) LV (Completed) LT (Completed) SE (Completed) AT (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-020872-49 Sponsor Protocol Number: PI10-Pr.CHOUKROUN-FRENCH Start Date*: 2013-04-18
    Sponsor Name:CHU Amiens
    Full Title: Étude randomisée, en double aveugle, versus placebo, évaluant chez des patients porteurs d'une MRC, non dialysés, l'effet du traitement par carbonate de sevelamer sur le contrôle des taux sériques ...
    Medical condition: Maladies Rénales Chroniques au stade 3b et 4 (DFG compris entre 15 et 45 ml/min)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10009119 Chronic renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003727-23 Sponsor Protocol Number: RRK3563 Start Date*: 2008-12-16
    Sponsor Name:University Hospital Birmingham NHS Foundation Trust
    Full Title: Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease?
    Medical condition: Chronic kidney disease stage 3 (eGFR 30-59 ml/min/1.73m2)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005107-33 Sponsor Protocol Number: 25659 Start Date*: 2012-01-13
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: dietary nutritional counseling or phosphate binders in the early stages of chronic kidney disease: effects on FGF 23
    Medical condition: chronic kidney failure
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10013346 Disorders of phosphorus metabolism LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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