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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney, Polycystic, Autosomal Dominant
• Intervention / Treatment: Drug: Cilnidipine; Drug: Imidapril

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: TANATRIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
eGFR	every 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Kidney Volume measured by MRI	every 3 months to every 2 years
Serum creatinine level	every 3 months to every 2 years
Induction of hemodialysis, cardiovascular events and central nervous vascular events	every 3 months to every 2 years

Collaborators and Investigators

• Sponsor: Ministry of Health, Labour and Welfare, Japan
• Investigators: Study Chair: Shigeo Horie, MD, Teikyo University

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: April 28, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Estimate): December 2, 2009
• Last Update Submitted That Met QC Criteria: December 1, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Hypertension; Autosomal Dominant Polycystic Kidney Disease; Angiotensin-II Receptor Blocker; Calcium Channel Blocker; Angiotensin converting enzyme inhibitor; Kidney Volume; eGFR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Ciliopathies; Hypertension; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Arthrogryposis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin-Converting Enzyme Inhibitors; Imidapril; Cilnidipine
• Other Study ID Numbers: ADPKDhypertension

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No