Hypertension on Chronic Maintenance HemodialysisPhase 4PICASSONCT01021501
The Pharmacokinetics of Nifedipine Controlled Release Tablets in Hypertensive Patients on Hemodialysis
A Phase 4 study of Hypertension on Chronic Maintenance Hemodialysis, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
This is a prospective, open, non-randomized, non-controlled study. 20 patients with hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients had mild to moderate hypertension and are receiving antihypertensive agents. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension on Chronic Maintenance Hemodialysis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Apr 2011
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females >= 18 years
- The patients are on chronic maintenance hemodialysis and dialyzed three times a week for 240 minutes.
- The patients have mild to moderate hypertension and are receiving antihypertensive agents.
- The dry weight of all patients is stable for at least 3 months. Dry weight is defined as the end-dialysis weight that was regularly reached without signs of dehydration or overhydration.
- Patients who have given a written informed consent.
- Females who are not yet in menopause should have an accepted contraception. A urine pregnancy test should be done if applicable, too.
Who cannot join
- Patients with an interdialytic increase of greater than 5% of body weight are excluded.
- Known hypersensitivity to nifedipine or any of the ingredients
- Moderate to severe hepatic insufficiency (ALT/AST>2 x ULN (= Upper Limit of Normal))
- Cardiovascular disease such as atrial fibrillation, congestive heart failure, valvular or ischemic heart disease, or stroke, or life-threatening arrhythmia
- fluid effusion
- inflammatory disease
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- malignancies
- Female patients who are pregnant or lactating.
- Other contraindications in package insert.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology, Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, 510180
Riguang LIU, PhD, 802081048157 ext. 8157, houqs@yahoo.cn
Lin Chen, 802081048157
About this study
Official title: the Effect of Nifedipine Controlled Release Tablets in Hypertensive Patients on Chronic Maintenance Hemodialysis and the Influence of Hemodialysis on the Plasma Concentration of Nifedipine
This is a prospective, open, non-randomized, non-controlled study. 20 patients with hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients had mild to moderate hypertension and are receiving antihypertensive agents.
This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures in patients with chronic hemodialysis by using ABPM and measuring the drug plasma concentrations. For the purpose of investigating the influence of hemodialysis on the drug plasma concentration as well as its efficacy, it should be necessary to assign the subjects with the Adalat monotherapy. Since most patients in the hemodialysis center will be those who need and already receive combination therapy, it would be practical to start Adalat 60mg/day monotherapy to remain similar antihypertensive effect when discontinuing the previous treatment in this study population to be screened and enrolled. And taking into the consideration of clinical practice, few patients undergoing hemodialysis could be well controlled by low dose Adalat 30mg/day alone. So this study will evaluate the effect and safety of Adalat GITS 60mg/day alone and thereafter the influence of hemodialysis on the drug plasma concentration without any other possible drug interaction. The agents are given orally once a day at 08:00h and patients are followed for at least 4 weeks. After that,the patients whose blood pressure are well controlled by Adalat GITS 60mg/day by office blood pressure would be enrolled for further ABPM assessment and plasma concentration evaluation.
Read the detailed description
Calcium channel blockers are widely used to reduce blood pressure in hypertensive patients on hemodialysis. They are useful I patients with left ventricular hypertrophy, diastolic dysfunction and stable angina pectoris. Adalat GITS, a long-acting dihydropyridine calcium channel blocker, has been used as one of first choices to treat the hypertension because of its effective hypotensive potency and relative absence of side effects compared with the short-acting agent. Antihypertensive effects of calcium channel blockers largely depend on their plasma concentrations, a rapid increase in blood pressure may occur as circulating levels of such blockers decrease after hemodialysis. This rapid fluctuation in blood pressure may evoke rapid alteration in hemodynamics. Luik et al. show that pre- or post-dialysis blood pressure measurements in patients with hemodialysis may be misleading for determining the blood pressure. Ambulatory pressure monitoring (ABPM) may be more useful for estimating blood pressure control in the dialysed patients. For most patients on dialysis, the goal office blood pressure is less than an average value below 150/90 mmHg on no medication. The reasonable target goal of mean ambulatory blood pressure is less than 135/85 mmHg during the day and less than 120/80 mmHg at night.
There is need of more convincing data to demonstrate the effect of Adalat GITS on hemodialytic patients by using ABPM and investigating the plasma concentrations. This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures in patients with chronic hemodialysis by using ABPM and measuring the drug plasma concentrations.
This is a prospective, open, non-randomized, non-controlled study. 20 patients with hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients had mild to moderate hypertension and are receiving antihypertensive agents.
All antihypertensive agents received by patients screened were withdrawn and patients are assigned to receive only nifedipine controlled release tablets 60mg/day. The agents are given orally once a day at 08:00h and patients are followed for at least 4 weeks. After 4 weeks of antihypertensive treatment, 20 patients with adequate blood pressure achieved (pre-hemodialysis office blood pressure < 140/90 mmHg) will be recruited into the study. If adequate blood pressure is not achieved, the patients will be excluded.
After patients have achieved adequate blood pressure (pre-hemodialysis office blood pressure < 140/90 mmHg) at enrollment, 24-hour ambulatory blood pressure monitoring (ABPM) is immediately performed on the day of hemodialysis within the subsequent two days. The administration of Adalat will continue as previously until the morning of the hemodialytic day with AMPM and blood samplings for study. The blood was sampled just before, 1 hour after, 2 hour after and 3 hour after the start of hemodialysis, and immediately after hemodialysis to measure circulating levels of nifedipine and the corresponding time points on the next hemodialysis-free day.
The 24-hour ABPM is performed in each enrolled patient on the day of hemodialysis. The monitoring is started at 08:00 h when the drugs are given. The device is programmed to measure blood pressure every 30 min (from 08:00 h to 21:00 h) and every 60 min (from 21:00 h to 08:00 h).
- Being tested
- nifedipine controlled release tablets
- Keywords
- nifedipine controlled release tablets, hypertensive, chronic maintenance hemodialysis, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nifedipine controlled release tabletsDrug
Also called Adalat GITS
nifedipine controlled release tablets 60mg/day for at least 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| nifedipine controlled release tablets | Experimental | Prospective, open, non-randomized, non-controlled study to evaluate the effect and safety of nifedipine controlled release tablets in hypertensive patients on chronic maintenance hemodialysis and the influence of hemodialysis on the plasma concentration of nifedipine Receives: Drug: nifedipine controlled release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect and safety of nifedipine controlled release tablets in patients on chronic maintenance hemodialysis by using ABPM.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertension on Chronic Maintenance HemodialysisStudies 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 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Junzhou Fu, Master, Principal investigator, Department of Nephrology, Guangzhou First Municipal People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021501
- Sponsor's protocol ID
- GZSYIC002
- Acronym
- PICASSO
- Status last verified
- Nov 2009
- First submitted
- 27 Nov 2009
- Last updated
- 30 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kojima M, Taniguchi M, Sato K, Ueda R, Dohi Y. Antihypertensive effects of long-acting calcium channel blockers on hemodialysis days--a randomized crossover trial between benidipine and nifedipine CR. Nephron Clin Pract. 2004;97(2):c49-53. doi: 10.1159/000078400.
PubMed 15218330Martre H, Sari R, Taburet AM, Jacobs C, Singlas E. Haemodialysis does not affect the pharmacokinetics of nifedipine. Br J Clin Pharmacol. 1985 Aug;20(2):155-8. doi: 10.1111/j.1365-2125.1985.tb05049.x.
PubMed 4041333
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Nifedipine Controlled Release Tablets in Hypertensive Patients on Chronic Maintenance Hemodialysis and the Influence of Hemodialysis on the Plasma Concentration of Nifedipine
- ClinicalTrials.gov ID
- NCT01021501
- Acronym / sponsor ID
- PICASSO / GZSYIC002
- Keywords
- nifedipine controlled release tablets, hypertensive, chronic maintenance hemodialysis, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 30 Nov 2009 (estimated)
- 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.
This is a prospective, open, non-randomized, non-controlled study. 20 patients with hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients had mild to moderate hypertension and are receiving antihypertensive agents.
This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures in patients with chronic hemodialysis by using ABPM and measuring the drug plasma concentrations. For the purpose of investigating the influence of hemodialysis on the drug plasma concentration as well as its efficacy, it should be necessary to assign the subjects with the Adalat monotherapy. Since most patients in the hemodialysis center will be those who need and already receive combination therapy, it would be practical to start Adalat 60mg/day monotherapy to remain similar antihypertensive effect when discontinuing the previous treatment in this study population to be screened and enrolled. And taking into the consideration of clinical practice, few patients undergoing hemodialysis could be well controlled by low dose Adalat 30mg/day alone. So this study will evaluate the effect and safety of Adalat GITS 60mg/day alone and thereafter the influence of hemodialysis on the drug plasma concentration without any other possible drug interaction. The agents are given orally once a day at 08:00h and patients are followed for at least 4 weeks. After that,the patients whose blood pressure are well controlled by Adalat GITS 60mg/day by office blood pressure would be enrolled for further ABPM assessment and plasma concentration evaluation.
Detailed description
Calcium channel blockers are widely used to reduce blood pressure in hypertensive patients on hemodialysis. They are useful I patients with left ventricular hypertrophy, diastolic dysfunction and stable angina pectoris. Adalat GITS, a long-acting dihydropyridine calcium channel blocker, has been used as one of first choices to treat the hypertension because of its effective hypotensive potency and relative absence of side effects compared with the short-acting agent. Antihypertensive effects of calcium channel blockers largely depend on their plasma concentrations, a rapid increase in blood pressure may occur as circulating levels of such blockers decrease after hemodialysis. This rapid fluctuation in blood pressure may evoke rapid alteration in hemodynamics. Luik et al. show that pre- or post-dialysis blood pressure measurements in patients with hemodialysis may be misleading for determining the blood pressure. Ambulatory pressure monitoring (ABPM) may be more useful for estimating blood pressure control in the dialysed patients. For most patients on dialysis, the goal office blood pressure is less than an average value below 150/90 mmHg on no medication. The reasonable target goal of mean ambulatory blood pressure is less than 135/85 mmHg during the day and less than 120/80 mmHg at night.
There is need of more convincing data to demonstrate the effect of Adalat GITS on hemodialytic patients by using ABPM and investigating the plasma concentrations. This study was designed to investigate effects of Adalat GITS on hemodialytic blood pressures in patients with chronic hemodialysis by using ABPM and measuring the drug plasma concentrations.
This is a prospective, open, non-randomized, non-controlled study. 20 patients with hypertension on chronic maintenance hemodialysis will be enrolled in the study. All patients had mild to moderate hypertension and are receiving antihypertensive agents.
All antihypertensive agents received by patients screened were withdrawn and patients are assigned to receive only nifedipine controlled release tablets 60mg/day. The agents are given orally once a day at 08:00h and patients are followed for at least 4 weeks. After 4 weeks of antihypertensive treatment, 20 patients with adequate blood pressure achieved (pre-hemodialysis office blood pressure < 140/90 mmHg) will be recruited into the study. If adequate blood pressure is not achieved, the patients will be excluded.
After patients have achieved adequate blood pressure (pre-hemodialysis office blood pressure < 140/90 mmHg) at enrollment, 24-hour ambulatory blood pressure monitoring (ABPM) is immediately performed on the day of hemodialysis within the subsequent two days. The administration of Adalat will continue as previously until the morning of the hemodialytic day with AMPM and blood samplings for study. The blood was sampled just before, 1 hour after, 2 hour after and 3 hour after the start of hemodialysis, and immediately after hemodialysis to measure circulating levels of nifedipine and the corresponding time points on the next hemodialysis-free day.
The 24-hour ABPM is performed in each enrolled patient on the day of hemodialysis. The monitoring is started at 08:00 h when the drugs are given. The device is programmed to measure blood pressure every 30 min (from 08:00 h to 21:00 h) and every 60 min (from 21:00 h to 08:00 h).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nifedipine controlled release tablets | Experimental | Drug: nifedipine controlled release tabletsProspective, open, non-randomized, non-controlled study to evaluate the effect and safety of nifedipine controlled release tablets in hypertensive patients on chronic maintenance hemodialysis and the influence of hemodialysis on the plasma concentration of nifedipine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females >= 18 years
- The patients are on chronic maintenance hemodialysis and dialyzed three times a week for 240 minutes.
- The patients have mild to moderate hypertension and are receiving antihypertensive agents.
- The dry weight of all patients is stable for at least 3 months. Dry weight is defined as the end-dialysis weight that was regularly reached without signs of dehydration or overhydration.
- Patients who have given a written informed consent.
Key exclusion criteria (9 listed)
- Patients with an interdialytic increase of greater than 5% of body weight are excluded.
- Known hypersensitivity to nifedipine or any of the ingredients
- Moderate to severe hepatic insufficiency (ALT/AST>2 x ULN (= Upper Limit of Normal))
- Cardiovascular disease such as atrial fibrillation, congestive heart failure, valvular or ischemic heart disease, or stroke, or life-threatening arrhythmia
- fluid effusion
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 |
|---|---|---|
| nifedipine controlled release tabletsAlso: Adalat GITSnifedipine controlled release tablets 60mg/day for at least 4 weeks | Drug | nifedipine controlled release tablets |
Primary outcome
To investigate the effect and safety of nifedipine controlled release tablets in patients on chronic maintenance hemodialysis by using ABPM.
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2009.
- Background: PubMed 15218330Kojima M, Taniguchi M, Sato K, Ueda R, Dohi Y. Antihypertensive effects of long-acting calcium channel blockers on hemodialysis days--a randomized crossover trial between benidipine and nifedipine CR. Nephron Clin Pract. 2004;97(2):c49-53. doi: 10.1159/000078400.
- Background: PubMed 4041333Martre H, Sari R, Taburet AM, Jacobs C, Singlas E. Haemodialysis does not affect the pharmacokinetics of nifedipine. Br J Clin Pharmacol. 1985 Aug;20(2):155-8. doi: 10.1111/j.1365-2125.1985.tb05049.x.
Related trials for Hypertension on Chronic Maintenance Hemodialysis
Not yet recruitingObservational study
Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients
Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD)
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.
Junzhou Fu, Master principal investigator
Department of Nephrology, Guangzhou First Municipal People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Hypertension on Chronic Maintenance Hemodialysis, run by Guangzhou First People's Hospital at 1 site in China.
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 6 inclusion and 9 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 30 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Junzhou Fu, master (802081048156, fujzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the effect and safety of nifedipine controlled release tablets in patients on chronic maintenance hemodialysis by using ABPM. (time frame: 2 days). 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 NCT01021501, which also lists 2 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 30 Nov 2009.