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March 30, 2020updated 12 Jul 2022 11:56am

AstraZeneca to stop DAPA-CKD trial of Farxiga early

AstraZeneca is set to stop the Phase III DAPA-CKD clinical trial of Farxiga (dapagliflozin) early after the drug showed encouraging efficacy profile.

AstraZeneca is set to stop the Phase III DAPA-CKD clinical trial of Farxiga (dapagliflozin) early after the drug showed encouraging efficacy profile.

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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Farxiga is an oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor. It is indicated to treat insufficiently controlled type 2 diabetes when given as an adjunct to diet and exercise.

The international, multi-centre, randomised, double-blinded DAPA-CKD study assessed 10mg Farxiga plus standard of care in chronic kidney disease (CKD) patients in 21 countries.

An independent data monitoring committee (DMC) said that the trial could be closed early based on safety and efficacy analysis, where the drug demonstrated a meaningful benefit in trial participants.

The primary endpoint of the study is a composite of worsening of renal function or death in CKD with or without type 2 diabetes.

AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Chronic kidney disease patients have limited treatment options, particularly those without type 2 diabetes.

“We are very pleased the data monitoring committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world.”

In August last year, the US Food and Drug Administration (FDA) awarded fast track designation for Farxiga to delay the progression of renal failure and prevent cardiovascular and renal death in CKD patients.

The company also reported data from a sub-analysis of the Phase III DAPA-HF trial of the drug in patients suffering from heart failure with reduced ejection fraction (HFrEF).

Data revealed that Farxiga decreased the incidence of the primary composite endpoint of heart failure worsening or cardiovascular death when compared to placebo.

The company reported that the trial met the primary endpoint in August last year.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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