Transdermal Clonidine in Chronic Hemodialysis Patients

Renal Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545530
• Other study ID #: KLD2015.0203
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2015
• Last updated: September 7, 2015
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: September 2015
• Source: Peking University People's Hospital
• Contact: Li ZUO, MD
• Phone: +861088324008
• Email: zuolimd[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

Drug:
• transdermal clonidine
2.5mg/patch per week

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	incidence of adverse effects compared with control group		4 weeks	Yes