相关临床试验
12
2 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
1
8.3%
已完成
4
33.3%
Enrolling By Invitation
1
8.3%
招募中
4
33.3%
终止
2
16.7%
暂无批准数据
- ProKidney reported statistically significant results from the Phase 2 REGEN-007 trial, showing rilparencel improved kidney function decline by 78% in patients with chronic kidney disease and diabetes. - The autologous cellular therapy demonstrated a clinically meaningful 4.6 mL/min/1.73m² per year improvement in eGFR slope (p<0.001) in patients receiving two scheduled injections. - No serious adverse events were observed, and the company plans to discuss using eGFR slope as a surrogate endpoint for accelerated FDA approval in an upcoming Type B meeting.
- ProKidney made significant strides in 2024, refining its Phase 3 program for rilparencel in advanced chronic kidney disease and securing FDA confirmation for potential accelerated approval pathway using eGFR slope as a surrogate endpoint. - Interim Phase 2 REGEN-007 data showed promising kidney function stabilization for 18 months in patients with advanced CKD and diabetes, with full data from approximately 20 patients expected in Q2 2025. - The company ended 2024 with $358 million in cash and marketable securities, extending its runway into mid-2027, while focusing on a single Phase 3 trial (PROACT 1) that could support a potential BLA submission.
- ProKidney focuses on its US-based Phase 3 trial of rilparencel for type 2 diabetes and chronic kidney disease, discontinuing a trial in Spain. - Amarna Therapeutics receives FDA guidance on its AM510 gene therapy for type 1 diabetes, aiming for tolerance induction. - Vertex's VX-880 continues to show potential in reducing or eliminating the need for insulin in type 1 diabetes patients. - PolarityTE screens first patient for SkinTE pivotal trial for diabetic foot ulcers, addressing a critical complication of diabetes.
- The FDA has confirmed that ProKidney's PROACT 1 Phase 3 study could be sufficient for full U.S. regulatory approval of rilparencel, a cellular therapy for chronic kidney disease (CKD). - ProKidney may pursue accelerated approval for rilparencel, with the FDA indicating that eGFR slope could serve as an acceptable surrogate endpoint. - ProKidney's cash reserves of $406.8 million are expected to support operations into 2027, facilitating the continued development of rilparencel. - Five posters were presented at the ASN Kidney Week, detailing the Phase 2 REGEN-007 study and rilparencel's mechanism of action.
- ProKidney will discontinue its ex-US Phase III trial (REGEN-016) of rilparencel for chronic kidney disease (CKD) to focus on the US market. - The strategic shift aims to expedite potential US registration and commercial launch of rilparencel, saving the company $150M-$175M. - Rilparencel, a regenerative cell therapy, has RMAT designation from the FDA and targets patients with type 2 diabetes and CKD. - Positive interim data from the REGEN-007 Phase 2 trial supports rilparencel's potential to preserve kidney function in CKD patients.
