Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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 controlled under 120/80 mmHg by candesartan (ARB) alone.

Condition or disease	Intervention/treatment	Phase
Kidney, Polycystic, Autosomal Dominant	Drug: Cilnidipine; Drug: Imidapril	Phase 2

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	160 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB
Study Start Date :	July 2009
Estimated Primary Completion Date :	June 2010
Estimated Study Completion Date :	November 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Cilnidipine; 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.	Drug: Cilnidipine; Cilnidipine up to 20 mg; Other Name: ATELEC
Active Comparator: Imidapril; 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.	Drug: Imidapril; Imidapril up to 10 mg per day; Other Name: TANATRIL

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. eGFR [ Time Frame: every 6 months ]

Secondary Outcome Measures :

1. Kidney Volume measured by MRI [ Time Frame: every 3 months to every 2 years ]
2. Serum creatinine level [ Time Frame: every 3 months to every 2 years ]
3. Induction of hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: every 3 months to every 2 years ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Shigeo Horie, MD	+81339642497	shorie@med.teikyo-u.ac.jp
Contact: Satoru Muto, MD, PhD	+81339642497	muto@med.teikyo-u.ac.jp

Locations

Japan
Department of Medicine II, Hokkaido Univserity School of Medicine	Recruiting
Sapporo, Hokkaido, Japan, 0608638
Contact: Toshio Mochizuki, MD +81117065915 mtoshi@med.hokudai.ac.jp
Principal Investigator: Toshio Mochizuki, MD
Toranomon Hospital Kajigaya, Kidney center	Not yet recruiting
Kawasaki, Kanagawa, Japan, 2138587
Contact: Yoshihumi Ubara, MD +81448775111 ext 6064 ubara@toranomon.gr.jp
Principal Investigator: Yoshihumi Ubara, MD
Department of Medicine II, Nippon Medical School	Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 1138602
Contact: Yasuhiko Iino, MD +81338222131 iinoyasuhiko@nms.ac.jp
Principal Investigator: Yasuhiko Iino, MD
Department of Urology, Teikyo University School of Medicine	Recruiting
Itabashi-ku, Tokyo, Japan, 1738605
Contact: Shigeo Horie, MD +81339642497 shorie@med.teikyo-u.ac.jp
Contact: Satoru Muto, MD +81339642497 muto@med.teikyo-u.ac.jp
Principal Investigator: Shigeo Horie, MD
Toranomon Hospital, Kidney center	Not yet recruiting
Minato-ku, Tokyo, Japan, 1058470
Contact: Kenmei Takaichi, MD +81335881111 ext 7065 takaichi@toranomon.gr.jp
Principal Investigator: Kenmei Takaichi, MD
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine	Active, not recruiting
Minato-ku, Tokyo, Japan, 1058471
Department of Urology, Kyorin University School of Medicine	Not yet recruiting
Mitaka, Tokyo, Japan, 1818611
Contact: Eiji HIgashihara, MD 81422475511 ehigashi@kyorin-u.ac.jp
Contact: Kikuo Nutahara, MD 81422475511 kinuta@kyorin-u.ac.jp
Principal Investigator: Eiji Higashihara, MD
Sub-Investigator: Kikuo Nutahara, MD
Department of Urology, National Hospital Organaization Chiba-East Hospital	Not yet recruiting
Chiba, Japan, 2608712
Contact: Koichi Kamura, MD +81432615171 ext 7607 kamura@cehpnet.com
Principal Investigator: Koichi Kamura, MD
Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences	Not yet recruiting
Niigata, Japan, 9518510
Contact: Ichiei Narita, MD +813252272193 naritai@med.niigata-u.ac.jp
Principal Investigator: Ichiei Narita, MD

Sponsors and Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

Study Chair:	Shigeo Horie, MD	Teikyo University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Shigeo Horie, M.D./Chairman of the Department of Urology at Teikyo University, Teikyo University, School of Medicine
ClinicalTrials.gov Identifier:	NCT00890279 History of Changes
Other Study ID Numbers:	ADPKDhypertension
First Posted:	April 29, 2009
Last Update Posted:	December 2, 2009
Last Verified:	December 2009

Keywords provided by Ministry of Health, Labour and Welfare, Japan:

Autosomal Dominant Polycystic Kidney Disease; Hypertension; Angiotensin-II Receptor Blocker; Calcium Channel Blocker	Angiotensin converting enzyme inhibitor; Kidney Volume; eGFR

Additional relevant MeSH terms:

Hypertension; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Kidney Diseases, Cystic; Abnormalities, Multiple; Congenital Abnormalities	Genetic Diseases, Inborn; Angiotensin-Converting Enzyme Inhibitors; Imidapril; Cilnidipine; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Calcium Channel Blockers; Membrane Transport Modulators; Antihypertensive Agents