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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Ministry of Health, Labour and Welfare, Japan

ClinicalTrials.gov Identifier:

NCT00890279

First received: April 28, 2009

Last updated: December 1, 2009

Last verified: December 2009

History of Changes

Purpose

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	Intervention	Phase
Kidney, Polycystic, Autosomal Dominant	Drug: Cilnidipine Drug: Imidapril	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: polycystic kidney disease

MedlinePlus related topics: Kidney Diseases

U.S. FDA Resources

Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Primary Outcome Measures:

eGFR [ Time Frame: every 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Kidney Volume measured by MRI [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]
Serum creatinine level [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]
Induction of hemodialysis, cardiovascular events and central nervous vascular events [ Time Frame: every 3 months to every 2 years ] [ Designated as safety issue: No ]


Estimated Enrollment:	160
Study Start Date:	July 2009
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	20 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890279

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


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
Study First Received:	April 28, 2009
Last Updated:	December 1, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 Angiotensin-Converting Enzyme Inhibitors	Imidapril Cilnidipine Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Membrane Transport Modulators Antihypertensive Agents

ClinicalTrials.gov processed this record on September 28, 2016

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