Chinese Medicine Treat for Hypertensive Renal Injury

NCT04078711 | Unknown Phase 2 DMC

• 1 other identifier: 2019NL-086-02
• Study Type: interventional
• Target: 520
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertension; Renal Injury

Keywords

hypertension; chronic kidney disease; traditional chinese medicine; early renal injury; albumin to creatinine ratio(UACR)

Outcome Measures

Primary Outcomes (1)

• albumin-to-creatinine ratio(UACR)

  UACR tested at baseline and each month. Microalbuminuria was defined as urinary ACR of at least 30mg/g.

  6 months

Secondary Outcomes (3)

• Ambulatory blood pressure level

  6 months

• Office blood pressure level 6/5000 Office blood pressure level

  6 months

• Traditional Chinese Medicine syndrome scores

  6 months

Study Arms (2)

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.

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.

Drug: Losartan 100Mg Tab; Drug: placebo

Interventions

Losartan 100Mg Tab DRUG

100Mg Tab, qd, po, 6 months

Also known as: Cozaar

Losartan & Placebo; losartan & qianyangyuyin

Qianyangyuyin 20g Granule DRUG

20g, Granule, bid, po, 6 months

losartan & qianyangyuyin

placebo DRUG

Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months

Also known as: placebo(qianyangyuyin)

Losartan & Placebo

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Hospital of Traditional Chinese Medicine: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator
• Affiliated Hospital of Liaoning University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator

Related Publications (11)

• 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.

  PMID: 19474763 BACKGROUND

• 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.

  PMID: 22386035 BACKGROUND

• 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.

  PMID: 23817082 BACKGROUND

• 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.

  PMID: 24352797 BACKGROUND

• 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.

  PMID: 17984482 BACKGROUND

• 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.

  PMID: 21388309 BACKGROUND

• 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.

  PMID: 21243736 BACKGROUND

• 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.

  PMID: 23747768 BACKGROUND

• 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.

  PMID: 11904577 BACKGROUND

• 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.

  PMID: 31080465 BACKGROUND

• 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.

  PMID: 17416265 BACKGROUND

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Zhuyuan Fang

  Jiangsu Province Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Ming Liu

  Jiangsu Province Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Ming Liu

CONTACT

13815885859; liumingxinghua@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 6, 2019
• Study Start: September 10, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 30, 2021
• Last Updated: September 6, 2019

Record last verified: 2019-09