Chronic Kidney DiseaseNCT03604003

The Role of Isolated Nocturnal Hypertension Pattern in Nondialysis CKD

A study testing potassium losartan in people with Chronic Kidney Disease, run by Fifth Affiliated Hospital, Sun Yat-Sen University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Isolated nocturnal hypertension (INH) has been studied among the general population and hypertensive patients. However, little insight is available on the prognostic effect of INH in patients with chronic kidney disease (CKD). Read more about this study

Who is it for?: Ages 14 to 75 years
Conditions the study is for: Chronic Kidney Disease
What is being tested?: potassium losartan
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: No sites listed yet
Study dates: 30 Nov 2018to 30 Dec 2023
Phase: Interventional
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 14 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

daytime BP <135/85mmHg，nighttime BP≥120/70mmHg；；
presence of CKD;
estimated GFR (eGFR)<90 mL⁄ min ⁄ 1.73 m2 (using the Modification of Diet in Renal Disease Study equation) but >30 mL⁄ min ⁄1.73 m2;
signed informed consent from participating patients.

Who cannot join

pregnancy;
tumor;
infection;
renal replacement;
history of drug or alcohol abuse;
night- or shift-work employment;

Show all 12Show fewer

treatment with steroids or hormonal therapy;
acute changes in eGFR >30% in the past 3 months;
presence of acquired immunodeficiency syndrome;
CV disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure,and grade III or IV retinopathy);
intolerance to ambulatory BP monitoring (ABPM);
inability to communicate and comply with all of the study requirements.

Trial locations and contacts

No sites are listed yet.

Cheng Wang, Doctor contact

18520762959

wt770716@163.com

Ye Zhu, Doctor contact

13600365603

yezhu84@hotmail.com

About this study

Official title: Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD

Read the detailed description

Patients with or without isolated nocturnal hypertension will be enrolled in this study, and the patients with isolated nocturnal hypertension will be randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan. Any patients who had any antihypertension medication at bedtime would withdrawal the drugs for 2 weeks before ABPM. Patients with isolated nocturnal hypertension will be randomly divided into two groups and received a bedtime or awakening dose of potassium losartan.

Conditions: Chronic Kidney Disease
Being tested: potassium losartan
Keywords: CKD, bedtime dosing, isolated nocturnal hypertension
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

potassium losartanDrug
Also called Kesiya
treated with bedtime or awakening doses of potassium losartan

Study groups in NCT03604003
Study group	Role	What they receive
bedtime dosing ARB for hypertension	Experimental	bedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension Receives: Drug: potassium losartan
bedtime dosing ARB for the prognosis	Experimental	bedtime administration of potassium losartan has benefit for the prognosis of CKD patients Receives: Drug: potassium losartan

What is being measured

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

renal events and Cardiovascular events
doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation
Measured: 5 years

Secondary outcomes (4)

proteinuria
24h proteinuria >1g
Measured: 5 years
renal function
eGFR<30ml/min/1.73m2
Measured: 5 years
Thickness of the medial membrane of the carotid artery
cIMT >1mm
Measured: 5 years
Left ventricle weight index
LVMI >115g/m2 (man) 和 >95g/m2 (woman)
Measured: 5 years

Timeline

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

30 Nov 201830 Dec 2023

First posted27 Jul 2018
Study start30 Nov 2018 (estimated)
Primary completion30 Jun 2021 (estimated)
Study completion30 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 252 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03604003
Sponsor's protocol ID: ZDWY.SNK.003
Status last verified: Jul 2018
First submitted: 4 Jul 2018
Last updated: 27 Jul 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
PubMed 17986697
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
Liu ZH. Nephrology in china. Nat Rev Nephrol. 2013 Sep;9(9):523-8. doi: 10.1038/nrneph.2013.146. Epub 2013 Jul 23.
PubMed 23877587
Zheng Y, Cai GY, Chen XM, Fu P, Chen JH, Ding XQ, Yu XQ, Lin HL, Liu J, Xie RJ, Wang LN, Ni ZH, Liu FY, Yin AP, Xing CY, Wang L, Shi W, Liu JS, He YN, Ding GH, Li WG, Wu GL, Miao LN, Chen N, Su Z, Mei CL, Zhao JY, Gu Y, Bai YK, Luo HM, Lin S, Chen MH, Gong L, Yang YB, Yang XP, Li Y, Wan JX, Wang NS, Li HY, Xi CS, Hao L, Xu Y, Fang JA, Liu BC, Li RS, Wang R, Zhang JH, Wang JQ, Lou TQ, Shao FM, Mei F, Liu ZH, Yuan WJ, Sun SR, Zhang L, Zhou CH, Chen QK, Jia SL, Gong ZF, Guan GJ, Xia T, Zhong LB; Prevalence, Awareness, and Treatment Rates in Chronic Kidney Disease Patients with Hypertension in China (PATRIOTIC) Collaborative Group. Prevalence, awareness, treatment, and control of hypertension in the non-dialysis chronic kidney disease patients. Chin Med J (Engl). 2013 Jun;126(12):2276-80.
PubMed 23786938
Wang C, Deng WJ, Gong WY, Zhang J, Zhang QZ, Ye ZC, Lou T. Nocturnal Hypertension Correlates Better With Target Organ Damage in Patients With Chronic Kidney Disease than a Nondipping Pattern. J Clin Hypertens (Greenwich). 2015 Oct;17(10):792-801. doi: 10.1111/jch.12589. Epub 2015 Jun 4.
PubMed 26041362
Luan FL, Norman SP. Intensive blood-pressure control in hypertensive chronic kidney disease. N Engl J Med. 2010 Dec 23;363(26):2564-5; author reply 2565-6. doi: 10.1056/NEJMc1011419. No abstract available.
PubMed 21175325
Hodgkinson J, Mant J, Martin U, Guo B, Hobbs FD, Deeks JJ, Heneghan C, Roberts N, McManus RJ. Relative effectiveness of clinic and home blood pressure monitoring compared with ambulatory blood pressure monitoring in diagnosis of hypertension: systematic review. BMJ. 2011 Jun 24;342:d3621. doi: 10.1136/bmj.d3621.
PubMed 21705406
Lv J, Ehteshami P, Sarnak MJ, Tighiouart H, Jun M, Ninomiya T, Foote C, Rodgers A, Zhang H, Wang H, Strippoli GF, Perkovic V. Effects of intensive blood pressure lowering on the progression of chronic kidney disease: a systematic review and meta-analysis. CMAJ. 2013 Aug 6;185(11):949-57. doi: 10.1503/cmaj.121468. Epub 2013 Jun 24.
PubMed 23798459
Fan HQ, Li Y, Thijs L, Hansen TW, Boggia J, Kikuya M, Bjorklund-Bodegard K, Richart T, Ohkubo T, Jeppesen J, Torp-Pedersen C, Dolan E, Kuznetsova T, Stolarz-Skrzypek K, Tikhonoff V, Malyutina S, Casiglia E, Nikitin Y, Lind L, Sandoya E, Kawecka-Jaszcz K, Imai Y, Ibsen H, O'Brien E, Wang J, Staessen JA; International Database on Ambulatory Blood Pressure In Relation to Cardiovascular Outcomes Investigators. Prognostic value of isolated nocturnal hypertension on ambulatory measurement in 8711 individuals from 10 populations. J Hypertens. 2010 Oct;28(10):2036-45. doi: 10.1097/HJH.0b013e32833b49fe.
PubMed 20520575
Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, O'Brien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003 Jun 12;348(24):2407-15. doi: 10.1056/NEJMoa022273.
PubMed 12802026
ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013 Oct;31(10):1925-38. doi: 10.1097/HJH.0b013e328364ca4c. No abstract available.
PubMed 24107724
O'Brien E, Sheridan J, O'Malley K. Dippers and non-dippers. Lancet. 1988 Aug 13;2(8607):397. doi: 10.1016/s0140-6736(88)92867-x. No abstract available.
PubMed 2899801
Iimuro S, Imai E, Watanabe T, Nitta K, Akizawa T, Matsuo S, Makino H, Ohashi Y, Hishida A; Chronic Kidney Disease Japan Cohort Study Group. Clinical correlates of ambulatory BP monitoring among patients with CKD. Clin J Am Soc Nephrol. 2013 May;8(5):721-30. doi: 10.2215/CJN.06470612. Epub 2013 Feb 14.
PubMed 23411432
Hering D. Predictive Role of Nighttime Blood Pressure in Response to Renal Denervation: Evidence From the DENER-HTN Study (Renal Denervation for Hypertension). Hypertension. 2017 Mar;69(3):398-400. doi: 10.1161/HYPERTENSIONAHA.116.08738. Epub 2017 Jan 23. No abstract available.
PubMed 28115511
Hansen TW, Li Y, Boggia J, Thijs L, Richart T, Staessen JA. Predictive role of the nighttime blood pressure. Hypertension. 2011 Jan;57(1):3-10. doi: 10.1161/HYPERTENSIONAHA.109.133900. Epub 2010 Nov 15.
PubMed 21079049

Want to know more?

Cheng Wang, Doctor

18520762959

wt770716@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

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prognostic Effect of Isolated Nocturnal Hypertension Pattern With Nondialysis CKD
ClinicalTrials.gov ID: NCT03604003
Acronym / sponsor ID: ZDWY.SNK.003
Conditions: Chronic Kidney Disease
Keywords: CKD, bedtime dosing, isolated nocturnal hypertension
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 252 participants (estimated)
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
Study start: 30 Nov 2018 (estimated)
Primary completion: 30 Jun 2021 (estimated)
Study completion: 30 Dec 2023 (estimated)
First posted: 27 Jul 2018 (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: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
bedtime dosing ARB for hypertension	Experimental	Drug: potassium losartanbedtime administration of potassium losartan has benefit for the isolated nocturnal hypertension
bedtime dosing ARB for the prognosis	Experimental	Drug: potassium losartanbedtime administration of potassium losartan has benefit for the prognosis of CKD patients

Who may qualify

Ages: 14 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

daytime BP <135/85mmHg，nighttime BP≥120/70mmHg；；
presence of CKD;
estimated GFR (eGFR)<90 mL⁄ min ⁄ 1.73 m2 (using the Modification of Diet in Renal Disease Study equation) but >30 mL⁄ min ⁄1.73 m2;
signed informed consent from participating patients.

Key exclusion criteria (12 listed)

pregnancy;
tumor;
infection;
renal replacement;
history of drug or alcohol abuse;

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
potassium losartanAlso: Kesiyatreated with bedtime or awakening doses of potassium losartan	Drug	bedtime dosing ARB for hypertension, bedtime dosing ARB for the prognosis

Primary outcome

renal events and Cardiovascular events
Time frame: 5 years
doubled creatine or renal replacement, myocardial infarction, heart failure, stroke, vascular reconstruction, peripheral vascular disease, non-traumatic amputation

4 secondary outcomes

proteinuria
Time frame: 5 years
renal function
Time frame: 5 years
Thickness of the medial membrane of the carotid artery
Time frame: 5 years
Left ventricle weight index
Time frame: 5 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
Background: PubMed 17986697Coresh J, Selvin E, Stevens LA, Manzi J, Kusek JW, Eggers P, Van Lente F, Levey AS. Prevalence of chronic kidney disease in the United States. JAMA. 2007 Nov 7;298(17):2038-47. doi: 10.1001/jama.298.17.2038.
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 23877587Liu ZH. Nephrology in china. Nat Rev Nephrol. 2013 Sep;9(9):523-8. doi: 10.1038/nrneph.2013.146. Epub 2013 Jul 23.
Background: PubMed 23786938Zheng Y, Cai GY, Chen XM, Fu P, Chen JH, Ding XQ, Yu XQ, Lin HL, Liu J, Xie RJ, Wang LN, Ni ZH, Liu FY, Yin AP, Xing CY, Wang L, Shi W, Liu JS, He YN, Ding GH, Li WG, Wu GL, Miao LN, Chen N, Su Z, Mei CL, Zhao JY, Gu Y, Bai YK, Luo HM, Lin S, Chen MH, Gong L, Yang YB, Yang XP, Li Y, Wan JX, Wang NS, Li HY, Xi CS, Hao L, Xu Y, Fang JA, Liu BC, Li RS, Wang R, Zhang JH, Wang JQ, Lou TQ, Shao FM, Mei F, Liu ZH, Yuan WJ, Sun SR, Zhang L, Zhou CH, Chen QK, Jia SL, Gong ZF, Guan GJ, Xia T, Zhong LB; Prevalence, Awareness, and Treatment Rates in Chronic Kidney Disease Patients with Hypertension in China (PATRIOTIC) Collaborative Group. Prevalence, awareness, treatment, and control of hypertension in the non-dialysis chronic kidney disease patients. Chin Med J (Engl). 2013 Jun;126(12):2276-80.
Background: PubMed 26041362Wang C, Deng WJ, Gong WY, Zhang J, Zhang QZ, Ye ZC, Lou T. Nocturnal Hypertension Correlates Better With Target Organ Damage in Patients With Chronic Kidney Disease than a Nondipping Pattern. J Clin Hypertens (Greenwich). 2015 Oct;17(10):792-801. doi: 10.1111/jch.12589. Epub 2015 Jun 4.
Background: PubMed 21175325Luan FL, Norman SP. Intensive blood-pressure control in hypertensive chronic kidney disease. N Engl J Med. 2010 Dec 23;363(26):2564-5; author reply 2565-6. doi: 10.1056/NEJMc1011419. No abstract available.
Background: PubMed 21705406Hodgkinson J, Mant J, Martin U, Guo B, Hobbs FD, Deeks JJ, Heneghan C, Roberts N, McManus RJ. Relative effectiveness of clinic and home blood pressure monitoring compared with ambulatory blood pressure monitoring in diagnosis of hypertension: systematic review. BMJ. 2011 Jun 24;342:d3621. doi: 10.1136/bmj.d3621.
Background: PubMed 23798459Lv J, Ehteshami P, Sarnak MJ, Tighiouart H, Jun M, Ninomiya T, Foote C, Rodgers A, Zhang H, Wang H, Strippoli GF, Perkovic V. Effects of intensive blood pressure lowering on the progression of chronic kidney disease: a systematic review and meta-analysis. CMAJ. 2013 Aug 6;185(11):949-57. doi: 10.1503/cmaj.121468. Epub 2013 Jun 24.
Background: PubMed 20520575Fan HQ, Li Y, Thijs L, Hansen TW, Boggia J, Kikuya M, Bjorklund-Bodegard K, Richart T, Ohkubo T, Jeppesen J, Torp-Pedersen C, Dolan E, Kuznetsova T, Stolarz-Skrzypek K, Tikhonoff V, Malyutina S, Casiglia E, Nikitin Y, Lind L, Sandoya E, Kawecka-Jaszcz K, Imai Y, Ibsen H, O'Brien E, Wang J, Staessen JA; International Database on Ambulatory Blood Pressure In Relation to Cardiovascular Outcomes Investigators. Prognostic value of isolated nocturnal hypertension on ambulatory measurement in 8711 individuals from 10 populations. J Hypertens. 2010 Oct;28(10):2036-45. doi: 10.1097/HJH.0b013e32833b49fe.
Background: PubMed 12802026Clement DL, De Buyzere ML, De Bacquer DA, de Leeuw PW, Duprez DA, Fagard RH, Gheeraert PJ, Missault LH, Braun JJ, Six RO, Van Der Niepen P, O'Brien E; Office versus Ambulatory Pressure Study Investigators. Prognostic value of ambulatory blood-pressure recordings in patients with treated hypertension. N Engl J Med. 2003 Jun 12;348(24):2407-15. doi: 10.1056/NEJMoa022273.
Background: PubMed 24107724ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013 Oct;31(10):1925-38. doi: 10.1097/HJH.0b013e328364ca4c. No abstract available.
Background: PubMed 2899801O'Brien E, Sheridan J, O'Malley K. Dippers and non-dippers. Lancet. 1988 Aug 13;2(8607):397. doi: 10.1016/s0140-6736(88)92867-x. No abstract available.
Individual participant dataSharing planned: Undecided

Related trials for Chronic Kidney Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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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.

Cheng Wang, Doctor contact

18520762959

wt770716@163.com

Ye Zhu, Doctor contact

13600365603

yezhu84@hotmail.com

Shaoxuan Liu study chair

GCP Office

Questions about this trial

What is this clinical trial studying?

A study testing potassium losartan in people with Chronic Kidney Disease, run by Fifth Affiliated Hospital, Sun Yat-Sen University.

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 12 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 27 Jul 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Cheng Wang, Doctor (18520762959, wt770716@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

renal events and Cardiovascular events (time frame: 5 years). 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 NCT03604003, which also lists 29 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 27 Jul 2018.