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A sign of faster access to innovative treatments for patients with chronic kidney disease

Ally Robert, Associate Director; James Beggs, Consultant | 3/13/2024

Consultants at Avalere Health have been exploring the ways in which manufacturers can optimize trial design for chronic kidney disease (CKD) to bring new and innovative treatments to market faster.

CKD results in a gradual loss of kidney function over time and affects more than 800 million people worldwide. The disease is associated with a significant burden both from the patient and healthcare system perspective, particularly in low- and middle-income countries, and is on the rise.

While current treatments are available for the management of CKD, there is still an unmet need for treatments that significantly slow the decline of kidney function across all subgroups of patients. Clinical trials in CKD are often very long and require a large number of patients, making them very expensive and discouraging pharmaceutical manufacturers from developing new treatments.

 

Part of the problem is the lack of validated kidney-specific surrogate endpoints

Part of the problem is the lack of validated kidney-specific surrogate endpoints; however, in the past few years, two new potential surrogates for long-term renal outcomes have emerged: eGFR slope and proteinuria. By providing an early indication of how effective a new treatment is going to be, rather than having to wait to see an effect in more traditional hard clinical endpoints, such as dialysis or death, it is hoped that these two endpoints can help reduce the length of clinical trials in CKD and, therefore, speed up patient access to new innovative treatments.

 

The challenge will be getting HTA agencies to trust and accept these new surrogate endpoints

We have observed an encouraging trend with increasing use of eGFR slope and proteinuria in Phase 2 and Phase 3 clinical trials, which we will be highlighting in our poster “Novel endpoints in chronic kidney disease (CKD): Trends in the use of eGFR slope and proteinuria as efficacy endpoints in clinical trials” at ISPOR US 2024. The more familiar HTA agencies and payers become with eGFR slope and proteinuria the more likely they are to accept them; however, there is still some work pharmaceutical manufacturers can do to help with this.

 

Partnering with you to make science accessible to every patient

If you would like to learn more about innovative endpoints and our recommendations to help drive HTA and payer acceptability, not only in CKD but in all disease areas, please come and talk to us at ISPOR US 2024 either at Poster CO129 during Poster Session 4 (Tues May 7 at 4pm) or meet us at Booth 413.

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