CTR20261163 GWZ003keli Kidney Diseases Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready landscape. This focused report examines CTR20261163—双参苓颗粒治疗慢性肾脏病的Ⅱ期临床试验—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why CTR20261163 is a hot trial to watch

Kidney Diseases is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. CTR20261163 is notable because it evaluates GWZ003keli in a Phase 2 design while 用药12周、24周后，估算肾小球滤过率（eGFR）*较基线的变化值。 *注：根据慢性肾脏病流行病学合作研究（CKD-EPI）公式计算。 serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

Design and endpoint interpretation

The phase label is only the starting point. Allocation is 随机化, masking is 双盲, and the intervention model is 平行分组. Planned enrollment of 120 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Primary: 用药12周、24周后，估算肾小球滤过率（eGFR）*较基线的变化值。 *注：根据慢性肾脏病流行病学合作研究（CKD-EPI）公式计算。 (用药12周、24周)
• Primary: 用药12周、24周后，eGFR的平均变化率。 (用药12周、24周)
• Primary: 用药12周、24周后，24h尿蛋白定量较基线的变化值。 (用药12周、24周)
• Primary: 用药12周、24周后，尿白蛋白/肌酐比值（UACR）较基线的变化值。 (用药12周、24周)
• Primary: 用药12周、24周后，UACR的复常率*及较基线下降≥30%的参与者百分比。 *注：UACR复常率：用药后UACR恢复至正常水平（＜30mg/g）的参与者百分比。 (用药12周、24周)

Benchmark readouts in the surrounding field

• An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (Doxercalciferol Capsules) in Pediatric Patients With Chronic Kidney Disease Stages 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis (Phase 3): Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12: Perecntage difference = -52.9(95% CI, -99.90 to -5.98); Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12 = 71.4 percentage of participants (95% Confidence Interval, 29.04 - 96.33)
• A Phase IIb, Multicenter, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination With Dapagliflozin Compared With Dapagliflozin in Patients With Chronic Kidney Disease and Albuminuria (Phase 2): Relative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12(Geometric Least Squares Mean) = 0.66 mg/g (90% Confidence Interval, 0.59 - 0.73); Relative Change in Urine Albumin-to-Creatinine Ratio (UACR) From Baseline to Week 12(Geometric Least Squares Mean): Percent change difference = -32.77(90% CI, -41.96 to -22.14), P-Value = <0.001; Percent Change Difference = -22.83(90% CI, -33.34 to -10.66), P-Value = 0.0038
• 1394-P: Impact of Finerenone on Albuminuria in Type 1 Diabetes by Baseline HbA1c Levels and Diabetes Duration: An Exploratory Analysis of the FINE-ONE Trial (Phase 2): UACR(6-month): P-Value = 0.0001; UACR(6-month): P-Value = 0.0001

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

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Asset and sponsor context

Drug & Asset context: Not reported

Company & Deal Intelligence context: Beijing Increase Innovative Drug Research Co., Ltd. — China

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Sequencing evidence: comparative data after the most relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.

Bottom line

CTR20261163 is a focused lens on Kidney Diseases development. Its value will be determined by whether GWZ003keli can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

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