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dRTA in Europe

Protocol code Study title Active substance Study phase Publication
B03CS Study to investigate the pharmacodynamics, safety and tolerability of repeated oral doses of ADV7103, in healthy subjects ADV7103
Placebo
Phase I
B21CS Study evaluating the efficacy, safety, tolerability and acceptability of ADV7103 compared to standard of care in distal renal tubular acidosis patients ADV7103 Phase II/III
B22CS Study evaluating the safety, tolerability and the efficacy of ADV7103 at long term in distal renal tubular acidosis patients ADV7103 Phase III

 

dRTA in the US

Protocol code Study title Active substance Study phase Publication
B23CS ARENA-2
A study evaluating ADV7103 in pediatric and adult subjects with distal renal tubular acidosis (dRTA)
ADV7103
Placebo
Phase II/III
B24CS ARENA-2 open-label extension study
A study evaluating the continued safety and efficacy of ADV7103 in subjects with primary distal renal tubular acidosis
ADV7103 Phase IIIB

 

Cystinuria in Europe

Protocol code Study title Active substance Study phase Publication
B03CS Study to investigate the pharmacodynamics, safety and tolerability of repeated oral doses of ADV7103, in healthy subjects ADV7103
Placebo
Phase I
B12CS Study to evaluate the efficacy, safety, tolerability and acceptability of repeated doses of ADV7103, after 7 days of treatment, in patients with cystinuria ADV7103 Phase II/III
B13CS Efficacy and safety exploration study in young children ADV7103 Phase II/III
B14CS Study to evaluate the safety, tolerability, efficacy, compliance and acceptability of alkalising treatments at long-term in patients with cystinuria ADV7103 Phase III

EU Clinical Trials Register

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ClinicalTrials.gov

Registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

ISRCTN registry

The ISRCTN registry is a primary clinical trial registry recognised by WHO and ICMJE that accepts all clinical research studies.