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Clinical trials for Renal Tubular Acidosis

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    9 result(s) found for: Renal Tubular Acidosis. Displaying page 1 of 1.
    EudraCT Number: 2013-003828-36 Sponsor Protocol Number: B22CS Start Date*: 2015-10-22
    Sponsor Name:Advicenne Pharma
    Full Title: A multicentre, open-label, extension study, evaluating the safety and tolerability and the efficacy of ADV7103 at long term in distal renal tubular acidosis patients.
    Medical condition: Distal renal tubular acidosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10038535 Renal tubular acidosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002988-25 Sponsor Protocol Number: B21CS Start Date*: 2015-10-22
    Sponsor Name:Advicenne Pharma
    Full Title: A multicentre, open-label, non-inferiority sequential study, evaluating the efficacy, safety, tolerability and acceptability of ADV7103 compared to standard of care in distal renal tubular acidosis...
    Medical condition: distal renal tubular acidosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038359 - Renal and urinary disorders 10038535 Renal tubular acidosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2018-004418-16 Sponsor Protocol Number: B24CS Start Date*: Information not available in EudraCT
    Sponsor Name:Advicenne SA
    Full Title: A Phase 3b Open-Label Extension of Study B23CS (ARENA 2) Evaluating the Continued Safety and Efficacy of ADV7103 in Subjects With Primary Distal Renal Tubular Acidosis (ARENA 2 Open-label Extensio...
    Medical condition: Distal renal tubular acidosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10038535 Renal tubular acidosis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-001824-36 Sponsor Protocol Number: 201201 Start Date*: 2012-07-12
    Sponsor Name:Medizinsiche Universität Wien, Klinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse
    Full Title: ORAL SODIUM BICARBONATE SUPPLEMENTATION IN PATIENTS WITH CHRONIC METABOLIC ACIDOSIS AND CHRONIC KIDNEY DISEASE
    Medical condition: Patients classified to have chronic kidney disease of stage 3 and 4 and chronic metabolic acidosis (venous serum HCO3- of <21mml/L on 2 separate measurements at least 1 day apart) should be include...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10066569 Chronic acidosis LLT
    14.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005045-31 Sponsor Protocol Number: 55668 Start Date*: 2016-09-13
    Sponsor Name:Erasmus MC
    Full Title: Switching to Tenofovir Alafenamide Fumarate or ABACavir in patients with Tenofovir Disoproxil Fumarate associated eGFR decline. A randomized clinical trial.
    Medical condition: Renal safety of switching from TDF to TAF or ABC in patients with TDF-associated eGFR-decline.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000226-38 Sponsor Protocol Number: 156-13-210 Start Date*: 2015-01-08
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Split-dose) in Subjects ...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) SE (Completed) HU (Completed) DK (Completed) NL (Completed) BE (Completed) ES (Completed) CZ (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-002768-24 Sponsor Protocol Number: 156-04-251 Start Date*: 2007-01-26
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablet Regimens in Adult Subjects with Autosomal Dominant ...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed) GB (Completed) DE (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-021430-64 Sponsor Protocol Number: RR10/9389 Start Date*: 2010-12-03
    Sponsor Name:University of Leeds
    Full Title: A randomised double blind placebo controlled clinical trial of anti B-cell therapy in patients with primary Sjögren’s syndrome.
    Medical condition: Primary Sjögren’s syndrome (PSS).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10040767 Sjogren's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-003062-12 Sponsor Protocol Number: PA-ADPKD-301 Start Date*: 2022-01-20
    Sponsor Name:Palladio Biosciences, Inc.
    Full Title: A Phase 3 Study of the Efficacy and Safety of Lixivaptan in Participants with Autosomal Dominant Polycystic Kidney Disease Consisting of a 1-year Double-blind, Placebo-controlled, Randomized Phase ...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) ES (Prematurely Ended) HU (Prematurely Ended) SK (Prematurely Ended) PL (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
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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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