Transdermal Clonidine in Chronic Hemodialysis Patients

NCT02545530 | Unknown DMC

• 1 other identifier: KLD2015.0203
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of chronic hemodialysis patients need a combination of several antihypertensive drugs for adequate BP control. The primary objective of this study is to evaluate whether transdermal clonidine can improve blood pressure control or decrease oral antihypertensive agents type or dosage and the secondary objective is to observe incidence of adverse reactions of transdermal clonidine in chronic hemodialysis patients.

Conditions

Renal Dialysis

Keywords

renal dialysis; hypertension; clonidine

Outcome Measures

Primary Outcomes (1)

• changes of blood pressure and oral antihypertensive agents' dosage and type

  mmHg of MAP decreased, changes of total antihypertensive agents' DDD and changes of total antihypertensive agents' types

  4 weeks

Secondary Outcomes (1)

• incidence of adverse effects compared with control group

  4 weeks

Study Arms (2)

transdermal clonidine+

ACTIVE COMPARATOR

apply one transdermal clonidine(2.5mg) each week for 4 weeks besides regular antihypertensive agents, reduce oral antihypertensive agents' dosage or type if blood pressure decreased.

Drug: transdermal clonidine

transdermal clonidine-

NO INTERVENTION

regular antihypertensive treatment

Interventions

transdermal clonidine DRUG

2.5mg/patch per week

transdermal clonidine+

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent;
• age: 18years to 80 years old；
• on hemodialysis for more than or equal to 3 months, not less than 3 times and 12 hours hemodialysis per week；
• cardiac function grade I or grade II(NYHA)；
• Using 1 or more than 1 oral antihypertensive drugs, pre-dialysis systolic blood pressure over 140mmHg or dialysis blood pressure over 90mmHg, post-dialysis systolic blood pressure over 130mmHg or diastolic blood pressure over 80mmHg

You may not qualify if:

• acute infection within 1 month；
• acute myocardial infarction/cardiac function grade IV/stroke within 3months；
• LVEF lower than 50% by echocardiography；
• Dry weight is not suitable by BCM evaluation, more than plus or minus 1kg；
• Inter-dialysis weight gain exceeds 5% of dry weight；
• Post-dialysis systolic blood pressure lower than 120mmHg and diastolic blood pressure lower than 70mmHg；
• The treatment regimen will be amended within 10 weeks and it is expected that the treatment amendment may affect blood pressure；
• Pregnancy or lactation or planning a pregnancy in 10 weeks；
• Expected to withdraw hemodialysis treatment in 10 weeks；
• Allergic to clonidine or its accessories；
• Undergoing other clinical studies, and the research interventions have an impact on blood pressure；
• Other clinical conditions that may affect the results

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Li Zuo, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li ZUO, MD

CONTACT

+861088324008; zuolimd@hotmail.com

Liangying Gan, MD

CONTACT

+861088324005; ganl@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of nephrology

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 10, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

CN (1)