AstraZeneca completes balcinrenone/dapagliflozin PK study; posts two new observational trials
Weekly roundup: a completed Phase I kidney study, a completed asthma registry, and two new real-world studies in gastric cancer and lymphoma.
AstraZeneca closed out a Phase I pharmacokinetics study and a Chinese asthma registry this week, while registering two new not-yet-recruiting observational studies in gastric cancer and B-cell lymphoma.
- Balcinrenone/dapagliflozin, Phase I, kidney failure (NCT07754331): This single-center, randomized, crossover study investigated the effect of hemodialysis on single oral dose pharmacokinetics, safety, and tolerability of balcinrenone/dapagliflozin in male and female participants with kidney failure on intermittent hemodialysis.1 The study is listed as completed, with 10 participants enrolled.1
- PRESENTII, observational, asthma (NCT06605885): This multicenter, observational, prospective study evaluated asthma biologic use features and clinical outcomes in China.2 The study is completed, with approximately 200 patients with a physician diagnosis of asthma and prescribed asthma biologics at visit 1 enrolled across 50 sites in different regions of China.2
- The study is not yet recruiting, with approximately 300 eligible participants to be enrolled throughout Germany.3
- The study is not yet recruiting, with an estimated enrollment of 532 participants, and covers patients newly diagnosed prior to the index date during the study identification period of 1 January 2020 to 1 July 2024 in registries and databases in Brazil, Canada, France and the United Kingdom.4
Fact check notes
- In the source
PRESENTII (NCT06605885) is a multicenter, observational, prospective study evaluating asthma biologic use and outcomes in China, completed, with approximately 200 patients enrolled across 50 sites.
The entry repeats the protocol's target enrollment ('approximately 200') rather than the actual final enrollment of 202 participants listed in the source's Design section; a minor numeric discrepancy. - Checker's notePRESENTII enrollment is stated as 'approximately 200' sourced from the protocol description, while the source's Design section lists the actual enrollment as 202 participants; the entry should note the final actual figure.
- Sentence removed
GRACE-DE, observational, gastric/gastroesophageal junction cancer (NCT07882212): This prospective, non-interventional, observational, multicentre study evaluates the real-world effectiveness and safety of AstraZeneca-developed and approved medicines used to treat gastric and/or oesophageal cancers in Germany.
copied source wording - Sentence removed
Module A evaluates durvalumab used perioperatively in combination with FLOT chemotherapy, followed by adjuvant durvalumab monotherapy, in adults with resectable gastric or gastro-oesophageal junction adenocarcinoma in routine clinical practice in Germany.
copied source wording - Sentence removed
WW-CLARITY (Clarity-BR), observational, diffuse large B-cell lymphoma (NCT07882576): This retrospective observational registry study is designed to characterise patient profiles, assess treatment patterns, evaluate clinical outcomes and explore COO testing patterns among adult patients with newly diagnosed DLBCL who have not previously received treatment and are receiving first-line treatment.
copied source wording
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.