parallel randomized trial

SOLID-DKD

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Diabetic Kidney Disease in Type 2 Diabetes

Type 2 diabetes (adults)Chronic kidney disease with diabetes NCT06415214S001370

Design

Randomized: 281
Start year: 2024
Treatment: 16 weeks, follow-up 18 weeks
Countries: China (72 sites)
Sponsor: Jiangsu Hengrui Pharmaceuticals (industry)
Eligibility: age 18 to 75; T2D with UACR 300 to below 3000 mg/g; eGFR 30 or more; HbA1c 6.5 to 10; BMI 20 to 40

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: full analysis
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	HRS-7535 30 mg tablet once daily HRS-7535 30 mg QD	RAS inhibitor in most; SGLT2i or finerenone allowed; glucose lowering drugs adjusted; lifestyle: not reported	93	93	84
A2	HRS-7535 90 mg tablet once daily HRS-7535 90 mg QD	RAS inhibitor in most; SGLT2i or finerenone allowed; glucose lowering drugs adjusted; lifestyle: not reported	94	94	87
A3	Placebo Placebo	RAS inhibitor in most; SGLT2i or finerenone allowed; glucose lowering drugs adjusted; lifestyle: not reported	94	93	89

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	HRS-7535 30 mg tablet once daily A1	HRS-7535 90 mg tablet once daily A2	Placebo A3
age	mean (years)	54.8	55.7	56.6
age	sd (years)	10.1	10.7	9.7
asian	n	93	94	93
asian	percent	100	100	100
bmi	mean (kg/m2)	27.2	26.5	26.3
bmi	sd (kg/m2)	4.2	3.3	3.7
diabetes duration	median (years)	11.9	14.0	13.6
diabetes duration	q1 (years)	4.3	7.1	8.8
diabetes duration	q3 (years)	18.4	20.6	18.1
egfr: less than 60	n	37	31	22
egfr: less than 60	percent	39.8	33.0	23.7
egfr	mean (mL/min/1.73 m2)	74.2	77.6	80.7
egfr	sd (mL/min/1.73 m2)	27.0	26.8	25.4
female	n	23	24	26
female	percent	24.7	25.5	28.0
hba1c	mean (percent)	7.55	7.61	7.66
hba1c	sd (percent)	0.86	0.89	0.97
insulin use	n	53	62	54
insulin use	percent	57.0	66.0	58.1
metformin use	n	48	50	60
metformin use	percent	51.6	53.2	64.5
sbp	mean (mmHg)	128.6	129.6	129.6
sbp	sd (mmHg)	13.6	12.8	11.4
sglt2i use	n	59	62	60
sglt2i use	percent	63.4	66.0	64.5
uacr	median (mg/g)	634	781	788
uacr	q1 (mg/g)	445	590	484
uacr	q3 (mg/g)	1174	1301	1329
weight	mean (kg)	75.7	73.7	72.6
weight	sd (kg)	13.9	13.3	12.5

Analyses this trial contributes to

Results

59 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	change	-0.62 percent		81	hypothetical; full analysis; R0004355:Supplement Table S3
16	A1 vs A3	md	-0.71 percent	-0.94 to -0.48		hypothetical; full analysis; R0004355:Results
16	A2	change	-1.01 percent		69	hypothetical; full analysis; R0004355:Supplement Table S3
16	A2 vs A3	md	-1.09 percent	-1.32 to -0.86		hypothetical; full analysis; R0004355:Results
16	A3	change	0.08 percent		89	hypothetical; full analysis; R0004355:Supplement Table S3

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	responders			51 / 93	hypothetical; full analysis; R0004355:Supplement Table S3
16	A1 vs A3	rd	26.9	13.3 to 40.5		hypothetical; full analysis; R0004355:Supplement Table S3
16	A2	responders			70 / 94	hypothetical; full analysis; R0004355:Supplement Table S3
16	A2 vs A3	rd	46.5	33.8 to 59.2		hypothetical; full analysis; R0004355:Supplement Table S3
16	A3	responders			26 / 93	hypothetical; full analysis; R0004355:Supplement Table S3

Level 2 or 3 hypoglycemia (participants) (9 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	8 / 93	not stated; safety; R0004355:Table 2
A1	events	0 / 93	not stated; safety; R0004355:Table 2
A1	events	15 / 93	not stated; safety; R0004355:Table 2
A2	events	17 / 94	not stated; safety; R0004355:Table 2
A2	events	0 / 94	not stated; safety; R0004355:Table 2
A2	events	2 / 94	not stated; safety; R0004355:Table 2
A3	events	0 / 93	not stated; safety; R0004355:Table 2
A3	events	2 / 93	not stated; safety; R0004355:Table 2
A3	events	7 / 93	not stated; safety; R0004355:Table 2

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	change	-3.1 mmHg	1.23		93	not stated; safety; R0004355:Supplement Table S5
16	A1 vs A3	md	-1.1 mmHg		-4.3 to 2.1		not stated; safety; R0004355:Supplement Table S5
16	A2	change	-5.5 mmHg	1.20		94	not stated; safety; R0004355:Supplement Table S5
16	A2 vs A3	md	-3.5 mmHg		-6.7 to -0.4		not stated; safety; R0004355:Supplement Table S5
16	A3	change	-2.0 mmHg	1.20		93	not stated; safety; R0004355:Supplement Table S5

Percent body weight change (5 lines; O10)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
16	A1	percent change	-1.16 percent		81	hypothetical; full analysis; R0004355:Supplement Table S3
16	A1 vs A3	md	-0.61 percent	-1.60 to 0.37		hypothetical; full analysis; R0004355:Results
16	A2	percent change	-3.50 percent		69	hypothetical; full analysis; R0004355:Supplement Table S3
16	A2 vs A3	md	-2.95 percent	-3.94 to -1.95		hypothetical; full analysis; R0004355:Results
16	A3	percent change	-0.55 percent		89	hypothetical; full analysis; R0004355:Supplement Table S3

Acute kidney injury (3 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	1 / 93	not stated; safety; R0004355:Table 2
A2	events	0 / 94	not stated; safety; R0004355:Table 2
A3	events	1 / 93	not stated; safety; R0004355:Table 2

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 93	not stated; safety; R0004355:Table 2
A2	events	0 / 94	not stated; safety; R0004355:Table 2
A3	events	0 / 93	not stated; safety; R0004355:Table 2

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	5 / 93	not stated; safety; R0004355:Table 2
A2	events	4 / 94	not stated; safety; R0004355:Table 2
A3	events	2 / 93	not stated; safety; R0004355:Table 2

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 93	not stated; safety; R0004355:Table 2
A2	events	1 / 94	not stated; safety; R0004355:Table 2
A3	events	0 / 93	not stated; safety; R0004355:Table 2

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	18 / 93	not stated; safety; R0004355:Table 2
A2	events	33 / 94	not stated; safety; R0004355:Table 2
A3	events	3 / 93	not stated; safety; R0004355:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	8 / 93	not stated; safety; R0004355:Table 2
A2	events	23 / 94	not stated; safety; R0004355:Table 2
A3	events	3 / 93	not stated; safety; R0004355:Table 2

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	9 / 93	not stated; safety; R0004355:Table 2
A2	events	11 / 94	not stated; safety; R0004355:Table 2
A3	events	3 / 93	not stated; safety; R0004355:Table 2

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 93	not stated; safety; R0004355:Table 2
A2	events	0 / 94	not stated; safety; R0004355:Table 2
A3	events	0 / 93	not stated; safety; R0004355:Table 2

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 93	not stated; safety; R0004355:Table 2
A2	events	0 / 94	not stated; safety; R0004355:Table 2
A3	events	0 / 93	not stated; safety; R0004355:Table 2

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 93	not stated; safety; R0004355:Table 2
A2	events	0 / 94	not stated; safety; R0004355:Table 2
A3	events	0 / 93	not stated; safety; R0004355:Table 2