Transdermal Clonidine in Chronic Hemodialysis Patients

Transdermal Clonidine on Blood Pressure of Chronic Hemodialysis Patients: A Randomized Crossover Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Renal Dialysis
• Intervention / Treatment: Drug: transdermal clonidine

Detailed Description

It's a randomised crossover clinical trial. Subjects: chronic hemodialysis patients. All subjects will be randomised to 2 groups. Subjects in first group will receive 4 weeks transdermal clonidine plus regular antihypertensive agents treatments first, 2weeks wash-out then and 4 weeks antihypertensive agents without transdermal clonidine. The other group will receive 4 weeks antihypertensive agents without transdermal clonidine first, 2weeks wash-out then and 4 weeks transdermal clonidine plus regular antihypertensive agents treatments. Ambulatory blood pressure, echocardiography, and biochemistry will be detected.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Li Zuo, MD; Phone Number: +861088324008; Email: zuolimd@hotmail.com
      • Contact: Liangying Gan, MD; Phone Number: +861088324005; Email: Ganl@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. signed informed consent;
2. age: 18years to 80 years old；
3. on hemodialysis for more than or equal to 3 months, not less than 3 times and 12 hours hemodialysis per week；
4. cardiac function grade I or grade II(NYHA)；
5. 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

Exclusion Criteria:

1. acute infection within 1 month；
2. acute myocardial infarction/cardiac function grade IV/stroke within 3months；
3. LVEF lower than 50% by echocardiography；
4. Dry weight is not suitable by BCM evaluation, more than plus or minus 1kg；
5. Inter-dialysis weight gain exceeds 5% of dry weight；
6. Post-dialysis systolic blood pressure lower than 120mmHg and diastolic blood pressure lower than 70mmHg；
7. Begin or stop recombinant human erythropoietin treatment within 2 weeks before inclusion or 10 weeks after inclusion;
8. Adjust recombinant human erythropoietin dosage to more than 2times or less than half original dosage within 2 weeks before inclusion or 10 weeks after inclusion；
9. The treatment regimen will be amended within 10 weeks and it is expected that the treatment amendment may affect blood pressure；
10. Pregnancy or lactation or planning a pregnancy in 10 weeks；
11. Expected to withdraw hemodialysis treatment in 10 weeks；
12. Allergic to clonidine or its accessories；
13. Undergoing other clinical studies, and the research interventions have an impact on blood pressure；
14. Other clinical conditions that may affect the results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: transdermal clonidine+; 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; 2.5mg/patch per week
No Intervention: transdermal clonidine-; regular antihypertensive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
incidence of adverse effects compared with control group	4 weeks

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Li Zuo, MD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 7, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: hypertension; renal dialysis; clonidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympatholytics; Clonidine
• Other Study ID Numbers: KLD2015.0203