Kidney, Polycystic, Autosomal DominantPhase 2NCT00890279
Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)
A Phase 2 study testing Cilnidipine and Imidapril in people with Kidney, Polycystic, Autosomal Dominant, run by Ministry of Health, Labour and Welfare, Japan at 9 sites in Japan.
Trial summary
This phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not… 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?
- Cilnidipine and Imidapril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 9 sitesJapan
- Study dates
- Jul 2009to Nov 2012
- Phase
- Phase 2
- 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 120/80 mmHg
- Age between 20 and 60 years old
- eGFR more than 30 ml/min/1.73m2
- 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
9 sites in 1 country.
9 sites in 1 country
Japan9 sites, 8 recruiting
- Not yet recruiting
Department of Medicine II, Nippon Medical School
Bunkyo-ku, Tokyo, 1138602
Yasuhiko Iino, MD, +81338222131, iinoyasuhiko@nms.ac.jp
Yasuhiko Iino, MD
- Not yet recruiting
Department of Urology, National Hospital Organaization Chiba-East Hospital
Chiba, Chiba, 2608712
Koichi Kamura, MD, +81432615171 ext. 7607, kamura@cehpnet.com
Koichi Kamura, MD
- Not yet recruiting
Toranomon Hospital Kajigaya, Kidney center
Kawasaki, Kanagawa, 2138587
Yoshihumi Ubara, MD, +81448775111 ext. 6064, ubara@toranomon.gr.jp
Yoshihumi Ubara, MD
- Not yet recruiting
Toranomon Hospital, Kidney center
Minato-ku, Tokyo, 1058470
Kenmei Takaichi, MD, +81335881111 ext. 7065, takaichi@toranomon.gr.jp
Kenmei Takaichi, MD
- Active, not recruiting
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
Minato-ku, Tokyo, 1058471
- Not yet recruiting
Department of Urology, Kyorin University School of Medicine
Mitaka, Tokyo, 1818611
Eiji HIgashihara, MD, 81422475511, ehigashi@kyorin-u.ac.jp
Kikuo Nutahara, MD, 81422475511, kinuta@kyorin-u.ac.jp
- Not yet recruiting
Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences
Niigata, Niigata, 9518510
Ichiei Narita, MD, +813252272193, naritai@med.niigata-u.ac.jp
Ichiei Narita, MD
- Recruiting
Department of Medicine II, Hokkaido Univserity School of Medicine
Sapporo, Hokkaido, 0608638
Toshio Mochizuki, MD, +81117065915, mtoshi@med.hokudai.ac.jp
Toshio Mochizuki, MD
- Recruiting
Department of Urology, Teikyo University School of Medicine
tabashi City, Tokyo, 1738605
Shigeo Horie, MD, +81339642497, shorie@med.teikyo-u.ac.jp
Satoru Muto, MD, +81339642497, muto@med.teikyo-u.ac.jp
About this study
Official title: Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB
This phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB) alone.
Read the detailed description
Maximum dosage of candesartan is 8 mg/day. Dosage of imidapril is in the range of 2.5-10 mg/day. Dosage of cilnidipine is in the range of 5-20mg/day.
- Conditions
- Kidney, Polycystic, Autosomal Dominant
- Being tested
- Cilnidipine, Imidapril
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, Hypertension, Angiotensin-II Receptor Blocker, Calcium Channel Blocker, Angiotensin converting enzyme inhibitor, Kidney Volume, eGFR
- 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.
CilnidipineDrug
Also called ATELEC
Cilnidipine up to 20 mg
ImidaprilDrug
Also called TANATRIL
Imidapril up to 10 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Cilnidipine | Experimental | The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group A, blood pressure is controlled by Candesartan plus Cilnidipine. Receives: Drug: Cilnidipine |
| Imidapril | Active comparator | The patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group B, blood pressure is controlled by Candesartan plus Imidapril. Receives: Drug: Imidapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR
Measured: every 6 months
Secondary outcomes (3)
Kidney Volume measured by MRI
Measured: every 3 months to every 2 years
Serum creatinine level
Measured: every 3 months to every 2 years
Induction of hemodialysis, cardiovascular events and central nervous vascular events
Measured: every 3 months to every 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Labour and Welfare, Japan
- Sponsor type
- Other government
- Investigators
- Shigeo Horie, MD, Study chair, Teikyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890279
- Sponsor's protocol ID
- ADPKDhypertension
- Status last verified
- Dec 2009
- First submitted
- 28 Apr 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB
- ClinicalTrials.gov ID
- NCT00890279
- Acronym / sponsor ID
- ADPKDhypertension
- Conditions
- Kidney, Polycystic, Autosomal Dominant
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, Hypertension, Angiotensin-II Receptor Blocker, Calcium Channel Blocker, Angiotensin converting enzyme inhibitor, Kidney Volume, eGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ministry of Health, Labour and Welfare, JapanOther government
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 29 Apr 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 phase II study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (ADPKD). This study examines the safety and efficacy of combination therapy by imidapril (ACEI) or cilnidipine (CCB) in ADPKD patients whose blood pressure is not controlled under 120/80 mmHg by candesartan (ARB) alone.
Detailed description
Maximum dosage of candesartan is 8 mg/day. Dosage of imidapril is in the range of 2.5-10 mg/day. Dosage of cilnidipine is in the range of 5-20mg/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilnidipine | Experimental | Drug: CilnidipineThe patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group A, blood pressure is controlled by Candesartan plus Cilnidipine. |
| Imidapril | Active comparator | Drug: ImidaprilThe patients whose blood pressure is not controlled under 120/80 with ARB alone are randomized into group A or B. In group B, blood pressure is controlled by Candesartan plus Imidapril. |
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 120/80 mmHg
- Age between 20 and 60 years old
- eGFR more than 30 ml/min/1.73m2
- 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 |
|---|---|---|
| CilnidipineAlso: ATELECCilnidipine up to 20 mg | Drug | Cilnidipine |
| ImidaprilAlso: TANATRILImidapril up to 10 mg per day | Drug | Imidapril |
Primary outcome
eGFR
Time frame: every 6 months
3 secondary outcomes
Kidney Volume measured by MRI
Time frame: every 3 months to every 2 years
Serum creatinine level
Time frame: every 3 months to every 2 years
Induction of hemodialysis, cardiovascular events and central nervous vascular events
Time frame: every 3 months to every 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
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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.
Shigeo Horie, MD study chair
Teikyo University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cilnidipine and Imidapril in people with Kidney, Polycystic, Autosomal Dominant, run by Ministry of Health, Labour and Welfare, Japan at 9 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 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shigeo Horie, MD (+81339642497, shorie@med.teikyo-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2009.