HypertensionPhase 2/3CHAIRNCT04078711

Chinese Medicine Treat for Hypertensive Renal Injury

A Phase 2/3 study testing Losartan 100Mg Tab and Qianyangyuyin 20g Granule in people with Hypertension and Renal Injury, run by Jiangsu Province Hospital of Traditional Chinese Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study evaluates whether the traditional chinese medicine (Qianyangyuyin formula) could prevent and treat early renal injury in patients with hypertension and microalbuminuria (defined as a urinary albumin to creatinine ratio between 30 and 300 mg/g) based on standard antihypertensive treatment. Read more about this study

Who is it for?: Ages 35 to 55 years
Conditions the study is for: Hypertension, Renal Injury
What is being tested?: Losartan 100Mg Tab and Qianyangyuyin 20g Granule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 520 participants
Where: No sites listed yet
Study dates: 10 Sep 2019to 30 Dec 2021
Phase: Phase 2/3
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 35 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Subject has primary hypertension(grades 2-3)
Subject has microalbuminuria [defined as a urinary albumin/creatinine ratio (UACR) between 30 and 300mg/g, and a eGFR at least 60ml/(min∙1.73m2)]
Subject has ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome
Subject voluntarily participates in the trial and signs informed consent

Who cannot join

Subject has secondary hypertension
Subject with pregnancy or lactating
Subject has serious life-threatening diseases, such as acute myocardial infarction, stroke, heart failure (NYHA IV), and malignant arrhythmia
Subject's liver function (AST or ALT) is 2 times greater than normal value
Subject has history of mental illness
Subject currently participates in other drug clinical trials

Trial locations and contacts

No sites are listed yet.

Ming Liu contact

13815885859

liumingxinghua@163.com

About this study

Official title: Qianyangyuyin Formula Prevent and Treat for Early Renal Injury in Hypertensive Patients

Read the detailed description

Hypertension is the main cardiovascular disease and the most important risk factor for severe lethal and disabling diseases such as stroke, myocardial infarction, heart failure, and chronic renal insufficiency. The higher the blood pressure level, the higher the risk of these diseases. Antihypertensive drugs can control blood pressure, and effectively reduce the risk of these serious complications. A multi-center, randomized, parallel, placebo-controlled clinical study was designed to explore the effectiveness and safety of early intervention of Chinese medicine (Qianyanguuyin formula) in improving urinary albumin to creatinine ratio (ACR), based on standard antihypertensive treatment (losartan 100mg qd, if necessary combined with calcium channel blockers). Patients were recruited if they were (1) age between 35 and 55 years old, (2) primary hypertension (grades 2-3 ), (3) microalbuminuria (ACR of 30-300 mg/g) and eGFR of at least 60 ml / (min∙1.73m2), (4) ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome. It's intented to form a standardized plan for the prevention and treatment of early renal injury in hypertensive patients.

Conditions: Hypertension, Renal Injury
Being tested: Losartan 100Mg Tab, Qianyangyuyin 20g Granule, placebo
Keywords: hypertension, chronic kidney disease, traditional chinese medicine, early renal injury, albumin to creatinine ratio(UACR)
Medical subject headings: Hypertension, Renal Insufficiency, Chronic

What participants receive

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

Losartan 100Mg TabDrug
Also called Cozaar
100Mg Tab, qd, po, 6 months
Qianyangyuyin 20g GranuleDrug
20g, Granule, bid, po, 6 months
placeboDrug
Also called placebo(qianyangyuyin)
Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months

Study groups in NCT04078711
Study group	Role	What they receive
losartan & qianyangyuyin	Experimental	Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Chinese Medicine (Qianyangyuyin granule) 20g by mouth, bid for 6 months. Receives: Drug: Losartan 100Mg Tab; Drug: Qianyangyuyin 20g Granule
Losartan & Placebo	Placebo comparator	Losartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Qianyangyuyin placebo 20g by mouth, bid for 6 months. Receives: Drug: Losartan 100Mg Tab; Drug: placebo

What is being measured

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

albumin-to-creatinine ratio(UACR)
UACR tested at baseline and each month. Microalbuminuria was defined as urinary ACR of at least 30mg/g.
Measured: 6 months

Secondary outcomes (3)

Ambulatory blood pressure level
ABPM was measured at baseline, 3 and 6 months. Both systolic and diastolic pressure was assessed. Hypertension was defined as mean ambulatory blood pressure of at least 130/80 mmHg.
Measured: 6 months
Office blood pressure level 6/5000 Office blood pressure level
Office blood pressure was measured at baseline and each month. Both systolic and diastolic pressure was assessed. Hypertension was defined as office blood pressure of at least 140/90 mmHg.
Measured: 6 months
Traditional Chinese Medicine syndrome scores
Self reported TCM syndrome scores at baseline and each month. Each main symptom is scored 0、2、4、6 (0 = no sympton; 6 = as heavy as can be), and each secondary symptom is scored 0、1、2、3(0=no symptom; 3= as heavy as can be).
Measured: 6 months

Timeline

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

10 Sep 201930 Dec 2021

First posted6 Sep 2019
Study start10 Sep 2019 (estimated)
Primary completion30 Jun 2021 (estimated)
Study completion30 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 520 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04078711
Sponsor's protocol ID: 2019NL-086-02
Acronym: CHAIR
Status last verified: Sep 2019
First submitted: 2 Sep 2019
Last updated: 6 Sep 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Gaziano TA, Bitton A, Anand S, Weinstein MC; International Society of Hypertension. The global cost of nonoptimal blood pressure. J Hypertens. 2009 Jul;27(7):1472-7. doi: 10.1097/HJH.0b013e32832a9ba3.
PubMed 19474763
Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.
PubMed 22386035
Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
PubMed 23817082
James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.
PubMed 24352797
Kunz R, Friedrich C, Wolbers M, Mann JF. Meta-analysis: effect of monotherapy and combination therapy with inhibitors of the renin angiotensin system on proteinuria in renal disease. Ann Intern Med. 2008 Jan 1;148(1):30-48. doi: 10.7326/0003-4819-148-1-200801010-00190. Epub 2007 Nov 5.
PubMed 17984482
Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G; ROADMAP Trial Investigators. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17. doi: 10.1056/NEJMoa1007994.
PubMed 21388309
Ruggenenti P, Fassi A, Ilieva A, Iliev IP, Chiurchiu C, Rubis N, Gherardi G, Ene-Iordache B, Gaspari F, Perna A, Cravedi P, Bossi A, Trevisan R, Motterlini N, Remuzzi G; BENEDICT-B Study Investigators. Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria: the BENEDICT-B randomized trial. J Hypertens. 2011 Feb;29(2):207-16. doi: 10.1097/hjh.0b013e32834069bd.
PubMed 21243736
Li X, Zhang J, Huang J, Ma A, Yang J, Li W, Wu Z, Yao C, Zhang Y, Yao W, Zhang B, Gao R; Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure Study Group. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013 Sep 17;62(12):1065-1072. doi: 10.1016/j.jacc.2013.05.035. Epub 2013 Jun 7.
PubMed 23747768
National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577
Joint Committee for Guideline Revision. 2018 Chinese Guidelines for Prevention and Treatment of Hypertension-A report of the Revision Committee of Chinese Guidelines for Prevention and Treatment of Hypertension. J Geriatr Cardiol. 2019 Mar;16(3):182-241. doi: 10.11909/j.issn.1671-5411.2019.03.014. No abstract available.
PubMed 31080465
Schmieder RE, Hilgers KF, Schlaich MP, Schmidt BM. Renin-angiotensin system and cardiovascular risk. Lancet. 2007 Apr 7;369(9568):1208-19. doi: 10.1016/S0140-6736(07)60242-6.
PubMed 17416265

Want to know more?

Ming Liu

13815885859

liumingxinghua@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Qianyangyuyin Formula Prevent and Treat for Early Renal Injury in Hypertensive Patients
ClinicalTrials.gov ID: NCT04078711
Acronym / sponsor ID: CHAIR / 2019NL-086-02
Conditions: Hypertension, Renal Injury
Keywords: hypertension, chronic kidney disease, traditional chinese medicine, early renal injury, albumin to creatinine ratio(UACR)
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 520 participants (estimated)
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese MedicineUniversity, hospital or other
Collaborators: Ministry of Science and Technology of the People´s Republic of China, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Study start: 10 Sep 2019 (estimated)
Primary completion: 30 Jun 2021 (estimated)
Study completion: 30 Dec 2021 (estimated)
First posted: 6 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
losartan & qianyangyuyin	Experimental	Drug: Losartan 100Mg Tab, Drug: Qianyangyuyin 20g GranuleLosartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Chinese Medicine (Qianyangyuyin granule) 20g by mouth, bid for 6 months.
Losartan & Placebo	Placebo comparator	Drug: Losartan 100Mg Tab, Drug: placeboLosartan 100mg tablet (if necessary combined with CCBs) by mouth, qd for 6 months and Qianyangyuyin placebo 20g by mouth, bid for 6 months.

Who may qualify

Ages: 35 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Subject has primary hypertension(grades 2-3)
Subject has microalbuminuria [defined as a urinary albumin/creatinine ratio (UACR) between 30 and 300mg/g, and a eGFR at least 60ml/(min∙1.73m2)]
Subject has ascendant hyperactivity of liver Yang or Yin deficiency in TCM syndrome
Subject voluntarily participates in the trial and signs informed consent

Key exclusion criteria (6 listed)

Subject has secondary hypertension
Subject with pregnancy or lactating
Subject has serious life-threatening diseases, such as acute myocardial infarction, stroke, heart failure (NYHA IV), and malignant arrhythmia
Subject's liver function (AST or ALT) is 2 times greater than normal value
Subject has history of mental illness

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Losartan 100Mg TabAlso: Cozaar100Mg Tab, qd, po, 6 months	Drug	Losartan & Placebo, losartan & qianyangyuyin
Qianyangyuyin 20g Granule20g, Granule, bid, po, 6 months	Drug	losartan & qianyangyuyin
placeboAlso: placebo(qianyangyuyin)Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months	Drug	Losartan & Placebo

Primary outcome

albumin-to-creatinine ratio(UACR)
Time frame: 6 months
UACR tested at baseline and each month. Microalbuminuria was defined as urinary ACR of at least 30mg/g.

3 secondary outcomes

Ambulatory blood pressure level
Time frame: 6 months
Office blood pressure level 6/5000 Office blood pressure level
Time frame: 6 months
Traditional Chinese Medicine syndrome scores
Time frame: 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Background: PubMed 19474763Gaziano TA, Bitton A, Anand S, Weinstein MC; International Society of Hypertension. The global cost of nonoptimal blood pressure. J Hypertens. 2009 Jul;27(7):1472-7. doi: 10.1097/HJH.0b013e32832a9ba3.
Background: PubMed 22386035Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, Chen M, He Q, Liao Y, Yu X, Chen N, Zhang JE, Hu Z, Liu F, Hong D, Ma L, Liu H, Zhou X, Chen J, Pan L, Chen W, Wang W, Li X, Wang H. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012 Mar 3;379(9818):815-22. doi: 10.1016/S0140-6736(12)60033-6.
Background: PubMed 23817082Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F; Task Force Members. 2013 ESH/ESC Guidelines for the management of arterial hypertension: the Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2013 Jul;31(7):1281-357. doi: 10.1097/01.hjh.0000431740.32696.cc. No abstract available.
Background: PubMed 24352797James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.
Background: PubMed 17984482Kunz R, Friedrich C, Wolbers M, Mann JF. Meta-analysis: effect of monotherapy and combination therapy with inhibitors of the renin angiotensin system on proteinuria in renal disease. Ann Intern Med. 2008 Jan 1;148(1):30-48. doi: 10.7326/0003-4819-148-1-200801010-00190. Epub 2007 Nov 5.
Background: PubMed 21388309Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G; ROADMAP Trial Investigators. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17. doi: 10.1056/NEJMoa1007994.
Background: PubMed 21243736Ruggenenti P, Fassi A, Ilieva A, Iliev IP, Chiurchiu C, Rubis N, Gherardi G, Ene-Iordache B, Gaspari F, Perna A, Cravedi P, Bossi A, Trevisan R, Motterlini N, Remuzzi G; BENEDICT-B Study Investigators. Effects of verapamil added-on trandolapril therapy in hypertensive type 2 diabetes patients with microalbuminuria: the BENEDICT-B randomized trial. J Hypertens. 2011 Feb;29(2):207-16. doi: 10.1097/hjh.0b013e32834069bd.
Background: PubMed 23747768Li X, Zhang J, Huang J, Ma A, Yang J, Li W, Wu Z, Yao C, Zhang Y, Yao W, Zhang B, Gao R; Efficacy and Safety of Qili Qiangxin Capsules for Chronic Heart Failure Study Group. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013 Sep 17;62(12):1065-1072. doi: 10.1016/j.jacc.2013.05.035. Epub 2013 Jun 7.
Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
Background: PubMed 31080465Joint Committee for Guideline Revision. 2018 Chinese Guidelines for Prevention and Treatment of Hypertension-A report of the Revision Committee of Chinese Guidelines for Prevention and Treatment of Hypertension. J Geriatr Cardiol. 2019 Mar;16(3):182-241. doi: 10.11909/j.issn.1671-5411.2019.03.014. No abstract available.
Background: PubMed 17416265Schmieder RE, Hilgers KF, Schlaich MP, Schmidt BM. Renin-angiotensin system and cardiovascular risk. Lancet. 2007 Apr 7;369(9568):1208-19. doi: 10.1016/S0140-6736(07)60242-6.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ming Liu contact

13815885859

liumingxinghua@163.com

Zhuyuan Fang principal investigator

Jiangsu Province Hospital of Traditional Chinese Medicine

Ming Liu study director

Jiangsu Province Hospital of Traditional Chinese Medicine

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Losartan 100Mg Tab and Qianyangyuyin 20g Granule in people with Hypertension and Renal Injury, run by Jiangsu Province Hospital of Traditional Chinese Medicine.

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Ming Liu (13815885859, liumingxinghua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

albumin-to-creatinine ratio(UACR) (time frame: 6 months). 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 NCT04078711, which also lists 11 linked publications.

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 6 Sep 2019.