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Diabetic Kidney DiseasePhase 2NCT05593575

Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease

A Phase 2 study of Diabetic Kidney Disease, run by Shanghai Pharmaceuticals Holding Co., Ltd at 45 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To preliminarily evaluate the efficacy and safety of the renin inhibitor (SPH3127 tablets) in reduction in proteinuria in patients with diabetic kidney disease with valsartan as the comparator, and determine the recommended dose. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetic Kidney Disease
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
45 sitesChina
Study dates
22 Mar 2023to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are diagnosed with type 2 diabetes who have been treated with at least one hypoglycemic therapy within 12 months prior to screening, with basically stable blood glucose level during screening;
  • During screening period, 120 mmHg ≤ sitting SBP ≤ 160 mmHg and sitting DBP < 110 mmHg;
  • Laboratory results before randomization should be: 1) at least twice the result of UCAR should be 30 mg/g ≤ UACR < 3000mg/g at W-8, W-4, W-2, and W0; 2) EGFR ≥ 45mL/min/1.73 m2 at W-4 and W0; 3) AST and ALT ≤ 2 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN at W0; 4) hemoglobin ≥ 90 g/L at W0; 5) 3.5 mmol/L ≤Serum potassium ≤ 4.8 mmol/L at W-4 and W0;
  • Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose;
  • Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, and understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial.

Who cannot join

  • Sitting SBP >140 mmHg and/or sitting DBP >90 mmHg at baseline (W0);
  • Color ultrasonography of renal artery indicated renal artery stenosis;
  • ① Acute renal insufficiency② acute nephritic syndrome, polycystic kidney, kidney stone, nephrotic syndrome; ③there is evidence that proteinuria originates from primary and secondary renal diseases other than hypertensive renal damage; ④ gross hematuria in the past one year.
  • During the screening/run-in period, major modifications need to be made to the subject's corresponding treatment regimen due to poor control of other underlying diseases based on the investigator's judgement;
  • Subjects with fundus lesions in malignant hypertensive, such as retinal hemorrhage and papilledema;
  • Subjects who need to continuously take glucocorticoids, anti-tumor chemical or biological agents, and non-steroidal anti-inflammatory drugs during the study period;
Show all 21Show fewer
  • Subjects with a history of acute myocardial infarction, coronary artery revascularization, Class IV heart failure, acute cerebral infarction, cerebral hemorrhage and transient ischemic attack within 3 months prior to randomization;
  • Subjects who have abnormal thyroid function tests with clinically significance;
  • Subjects with poor control of diabetes: HbA1c ≥ 9.0% at W0;
  • Subjects who have undergone major surgery within 3 months prior to screening or need to undergo major surgery during the trial;
  • Subjects whose medication adherence in the run-in period is < 80% or > 120%;
  • Subjects with a history of gastrointestinal surgery that may significantly change the absorption, distribution, metabolism and excretion of drugs;
  • Subjects who are known to be allergic to renin inhibitors, ARBs, ACEIs and their excipients, or those with hypersensitive constitution, or those who experience serious adverse reactions;
  • Women during pregnancy or lactating;
  • Subjects who need transplantation before randomization and during the trial;
  • Subjects with HIV infection, hepatitis B infection, hepatitis C infection, or other active infections;
  • Subjects who have a history of malignant tumor, and those who are suspected of malignant tumor;
  • Subjects with a past and current history of mental illness;
  • Subjects with a history of drug abuse or alcohol abuse within 2 years prior to screening;
  • Subjects who have participated in clinical trials of other drugs/devices as a subject within 3 months prior to screening;
  • Subjects with other diseases or conditions that the investigator considers not suitable for this trial.

Trial locations and contacts

45 sites in 1 country.

45 sites in 1 country

China45 sites

  • Beijing Tsinghua Changgeng Hospital

    Beijin

  • Beijing Anzhen Hospital，Capital Medical University

    Beijing

  • Beijing Tiantan Hospital，Capital Medical University

    Beijing

  • Beijing Tongren Hospital

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • The Second Norman Bethune Hospital of Jilin University

    Changchun, Jilin

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha

  • Chengdu Second People's Hospital

    Chengdu, Sichuan

  • Chengdu Seventh People's Hospital

    Chengdu

  • Sichuan Provincial People's Hospital

    Chengdu

  • West China Hospital of Sichuan University

    Chengdu

  • Shunde Hospital of Southern Medical University

    Foshan

  • The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China

    Fuzhou, Fujian

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • The First Affiliated Hospital，Sun Yat sen University

    Guangzhou, Guangdong

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou

  • Harbin Medical University Affiliated Fourth Hospital

    Harbin, Heilongjiang

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • Huizhou First Hospital

    Huizhou

  • Qilu Hospital of Shandong University

    Jinan

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan

  • Luoyang Third People's Hospital

    Luoyang, Henan

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Ningbo No.2 Hospital

    Ningbo

  • Affiliated Zhongshan Hospital of Fudan University，Qingpu Branch

    Shanghai

  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai

  • Shanghai Fengxian District Central Hospital

    Shanghai

  • Shanghai Minhang District Central Hospital

    Shanghai

  • Sheng Jing Hospital of China Medical University

    Shenyang

  • The First Affiliated Hospital of China Medical University

    Shenyang

  • The Seventh Affiliated Hospital，Sun Yat-sen University

    Shenzhen

  • Suining Central Hospital

    Suining, Sichuan

  • Second Hospital of Shanxi Medical University

    Taiyuan

  • Taizhou Municipal Hospital

    Taizhou, Zhejiang

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

  • The Third Hospital of Wuhan

    Wuhan, Hubei

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Xi'an Daxing Hospital

    Xi’an, Shanxi

  • Qinghai University Affiliated Hospital

    Xining, Qinghai

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia

  • Zigong Fourth People's Hospital

    Zigong, Sichuan

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Dose-finding Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Diabetic Kidney Disease

To preliminarily evaluate the efficacy and safety of the renin inhibitor (SPH3127 tablets) in reduction in proteinuria in patients with diabetic kidney disease with valsartan as the comparator, and determine the recommended dose.

Being tested
SPH3127+SPH3127matching placebo+valsartan matching placebo, SPH3127+valsartan matching placebo, SPH3127 matching placebo+valsartan
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPH3127+SPH3127matching placebo+valsartan matching placeboDrug

    1 tablet of SPH3127 (50 mg) ，3 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks

  • SPH3127+SPH3127matching placebo+valsartan matching placeboDrug

    2 tablet of SPH3127 (50 mg) ，2 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks

  • SPH3127+valsartan matching placeboDrug

    4 tablet of SPH3127 (50 mg) ， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks

  • SPH3127 matching placebo+valsartanDrug

    4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan, orally, once daily for 12 consecutive weeks

Study groups in NCT05593575
Study groupRoleWhat they receive
SPH3127-1Experimental1 tablet of SPH3127 (50 mg) ，3 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
Receives: Drug: SPH3127+SPH3127matching placebo+valsartan matching placebo
SPH3127-2Experimental2 tablet of SPH3127 (50 mg) ，2 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
Receives: Drug: SPH3127+SPH3127matching placebo+valsartan matching placebo
SPH3127-3Experimental4 tablet of SPH3127 (50 mg) ，1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
Receives: Drug: SPH3127+valsartan matching placebo
SPH3127-4Experimental4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan , orally, once daily for 12 consecutive weeks
Receives: Drug: SPH3127 matching placebo+valsartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change from baseline in UACR

    Percentage change from baseline in log-transformed UACR at the end of Week 12 of treatment

    Measured: at the end of Week 12 of treatment

Secondary outcomes (3)

  1. Percentage change from baseline in UACR

    Percentage change from baseline in log-transformed UACR at the end of Weeks 2, 4 and 8 of treatment

    Measured: at the end of Weeks 2, 4 and 8 of treatment

  2. Percentage change from baseline in UPCR

    Percentage change from baseline in log-transformed UPCR at the end of Weeks 2, 4, 8 and 12 of treatment

    Measured: at the end of Weeks 2, 4, 8 and 12 of treatment

  3. The change trend of eGFR

    The change trend of eGFR from baseline to the end of Weeks 2, 4, 8 and 12 of treatment

    Measured: from baseline to the end of Weeks 2, 4, 8 and 12 of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2022
  2. Study start22 Mar 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05593575
Sponsor's protocol ID
SPH3127-202
Status last verified
Jan 2025
First submitted
20 Oct 2022
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

    PubMed 38682786

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Diabetic Kidney Disease, run by Shanghai Pharmaceuticals Holding Co., Ltd at 45 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change from baseline in UACR (time frame: at the end of Week 12 of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05593575, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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