Kidney, Polycystic, Autosomal DominantPhase 4NCT00541853
CCB Safety Study in Treatment of Hypertension of ADPKD
A Phase 4 study testing Candesartan, Candesartan and Cilnidipine and Candesartan plus non-CCB agents in people with Kidney, Polycystic, Autosomal Dominant, run by Kyorin University at 6 sites in Japan.
Trial summary
This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Kidney, Polycystic, Autosomal Dominant
- What is being tested?
- Candesartan, Candesartan and Cilnidipine and Candesartan plus non-CCB agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesJapan
- Study dates
- Dec 2007to Nov 2012
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ADPKD patients.
- Blood pressure measured at out-patient setting is above 130/85 mmHg.
- Age between 20 and 60 years old.
- Plasma creatinine less than 2.0mg in man and 1.5mg in woman.
- Patients give informed consent.
Who cannot join
- Patients with severe cardiovascular and hepatic disorders.
- Patients with complications of central nervous vascular disorders.
- Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
- Patients currently engaging in other experimental protocol.
- Patients with intracranial aneurysma.
- Patients who must use diuretics.
- Allergic patients to Candesartan or Cilnidipine.
- Patients whose hypertension is not controlled by medication of this protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Japan6 sites
Department of Urology, National Hospital Organaization Chiba-East Hospital
Chiba, Chiba, 260-8712
Koichi Kamura, MD, 81+432615171 ext. 7607, kamura@cehpnet.com
Toranomon Hospital Kajigaya, Kidney center
Kanagawa, 213-8587
Yoshifumi Ubara, MD, 81+448775111 ext. 6064, ubara@toranomon.gr.jp
Kyorin University School of Medicine
Mitaka, Tokyo, 181-8611
Eiji Higashihara, M.D., 81+422475511 ext. 5813, ehigashi@kyorin-u.ac.jp
Kikuo Nutahara, M.D., 81-422475511 ext. 5815, kinuta@kyorin-u.ac.jp
Toranomon Hospital, Kidney center
Tokyo, 105-8470
Kenmei Tkaichi, MD, 81+335881111 ext. 7065, takaichi@toranomon.gr.jp
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Tokyo, 105-8471
Tatsuo Hosoya, MD, 81+334331111 ext. 3220, t-hosoya@jikei.ac.jp
Kazushige Hanaoka, MD, 81+334331111 ext. 3221, khanaoka@jikei.ac.jp
Department of Urology, Teikyo University, School of Medicine
Tokyo, 173-8605
Shigeo Horie, MD, 81+339641211, shorie@med.teikyo-u.ac.jp
Satoru Muto, MD, 81+33964-1211, muto@med.teikyo-u.ac.jp
About this study
Official title: Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients
This study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.
- Conditions
- Kidney, Polycystic, Autosomal Dominant
- Being tested
- Candesartan, Candesartan and Cilnidipine, Candesartan plus non-CCB agents
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, Hypertension, Angiotensin-2 Receptor Blocker, Calcium Channel Blocker, Kidney Volume
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
Candesartan upto 8mg
Candesartan and CilnidipineDrug
Candesartan upto 8mg per day and Cilnidipine upto 20mg per day
Candesartan plus non-CCB agentsDrug
Candesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | ADPKD patients with blood pressure above 130/85 are enrolled. The patients whose blood pressure is controlled under 130/85 by Candesartan alone are classified into group A. Receives: Drug: Candesartan |
| B | Experimental | The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group B, blood pressure is controlled by Candesartan plus Cilnidipine. If blood pressure is not lowered by Candesartan plus Cilnidipine alone, another antihypertensive agents except CCB and ACEI are allowable. Receives: Drug: Candesartan and Cilnidipine |
| C | Active comparator | The patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group C, blood pressure is controlled by Candesartan plus non-CCB agents such as beta- or alpha- adrenergic blockers or another ARB. Any CCB and ACEI are not allowable. Receives: Drug: Candesartan plus non-CCB agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney Volume measured by MRI.
Measured: Every year
Secondary outcomes (1)
Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events
Measured: any time during study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startDec 2007
- Study completionNov 2012 (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 Kidney, Polycystic, Autosomal DominantStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Investigators
- Eiji Higashihara, M.D., Study chair, Kyorin University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541853
- Sponsor's protocol ID
- ADPKDCCB
- Status last verified
- Oct 2007
- First submitted
- 9 Oct 2007
- Last updated
- 18 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PubMed 39356039Higashihara E, Nutahara K, Horie S, Muto S, Hosoya T, Hanaoka K, Tuchiya K, Kamura K, Takaichi K, Ubara Y, Itomura M, Hamazaki T. The effect of eicosapentaenoic acid on renal function and volume in patients with ADPKD. Nephrol Dial Transplant. 2008 Sep;23(9):2847-52. doi: 10.1093/ndt/gfn144. Epub 2008 Mar 27.
PubMed 18372389
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between ARB and ARB Plus CCB on Incidence of Renal and Cardiovascular Events in Hypertensive ADPKD Patients
- ClinicalTrials.gov ID
- NCT00541853
- Acronym / sponsor ID
- ADPKDCCB
- Conditions
- Kidney, Polycystic, Autosomal Dominant
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, Hypertension, Angiotensin-2 Receptor Blocker, Calcium Channel Blocker, Kidney Volume
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Dec 2007
- Study completion
- Nov 2012 (estimated)
- First posted
- 10 Oct 2007 (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 study examines the safety and efficacy of calcium channel blocker (CCB) in the treatment of hypertension of Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients. Angiotensin receptor blocker (ARB) was shown to have kidney protecting effects in patients with renal diseases including ADPKD, glomerulonephritis and diabetic nephropathy. In case whose blood pressure is not normalized by ARB alone, CCB is selected additionally. Recent research suggests genetic calcium channel disorder is responsible for the progression of ADPKD. It is not examined clinically if CCB treatment has any harmful effect to patients with ADPKD. This study examines the safety of Cilnidipine (CCB) in the ADPKD patients whose blood pressure is not controlled under 130/85 mmHg by Candesartan (ARB) alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: CandesartanADPKD patients with blood pressure above 130/85 are enrolled. The patients whose blood pressure is controlled under 130/85 by Candesartan alone are classified into group A. |
| B | Experimental | Drug: Candesartan and CilnidipineThe patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group B, blood pressure is controlled by Candesartan plus Cilnidipine. If blood pressure is not lowered by Candesartan plus Cilnidipine alone, another antihypertensive agents except CCB and ACEI are allowable. |
| C | Active comparator | Drug: Candesartan plus non-CCB agentsThe patients whose blood pressure is not controlled under 130/85 with ARB alone are randomized into group B or C. In group C, blood pressure is controlled by Candesartan plus non-CCB agents such as beta- or alpha- adrenergic blockers or another ARB. Any CCB and ACEI are not allowable. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ADPKD patients.
- Blood pressure measured at out-patient setting is above 130/85 mmHg.
- Age between 20 and 60 years old.
- Plasma creatinine less than 2.0mg in man and 1.5mg in woman.
- Patients give informed consent.
Key exclusion criteria (8 listed)
- Patients with severe cardiovascular and hepatic disorders.
- Patients with complications of central nervous vascular disorders.
- Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
- Patients currently engaging in other experimental protocol.
- Patients with intracranial aneurysma.
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 |
|---|---|---|
| CandesartanCandesartan upto 8mg | Drug | A |
| Candesartan and CilnidipineCandesartan upto 8mg per day and Cilnidipine upto 20mg per day | Drug | B |
| Candesartan plus non-CCB agentsCandesartan upto 8mg per day and other antihypertensive drugs except CCB and ACEI | Drug | C |
Primary outcome
Kidney Volume measured by MRI.
Time frame: Every year
1 secondary outcome
Serum creatinine, hemodialysis, cardiovascular events and central nervous vascular events
Time frame: any time during study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2007.
- Derived from this study: PubMed 39356039St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Derived from this study: PubMed 18372389Higashihara E, Nutahara K, Horie S, Muto S, Hosoya T, Hanaoka K, Tuchiya K, Kamura K, Takaichi K, Ubara Y, Itomura M, Hamazaki T. The effect of eicosapentaenoic acid on renal function and volume in patients with ADPKD. Nephrol Dial Transplant. 2008 Sep;23(9):2847-52. doi: 10.1093/ndt/gfn144. Epub 2008 Mar 27.
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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.
Eiji Higashihara, M.D. study chair
Kyorin University, School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candesartan, Candesartan and Cilnidipine and Candesartan plus non-CCB agents in people with Kidney, Polycystic, Autosomal Dominant, run by Kyorin University at 6 sites in Japan.
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 5 inclusion and 8 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 18 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. 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 Eiji Higashihara, M.D. (+81-422-47-5511 ext. 5813, ehigashi@kyorin-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney Volume measured by MRI. (time frame: Every year). 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 NCT00541853, 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 18 Oct 2007.