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

Primary Purpose

Kidney, Polycystic, Autosomal Dominant

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Cilnidipine
Imidapril
Sponsored by
Ministry of Health, Labour and Welfare, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney, Polycystic, Autosomal Dominant focused on measuring Autosomal Dominant Polycystic Kidney Disease, Hypertension, Angiotensin-II Receptor Blocker, Calcium Channel Blocker, Angiotensin converting enzyme inhibitor, Kidney Volume, eGFR

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine II, Hokkaido Univserity School of MedicineRecruiting
  • Toranomon Hospital Kajigaya, Kidney center
  • Department of Medicine II, Nippon Medical School
  • Department of Urology, Teikyo University School of MedicineRecruiting
  • Toranomon Hospital, Kidney center
  • Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
  • Department of Urology, Kyorin University School of Medicine
  • Department of Urology, National Hospital Organaization Chiba-East Hospital
  • Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cilnidipine

Imidapril

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

eGFR

Secondary Outcome Measures

Kidney Volume measured by MRI
Serum creatinine level
Induction of hemodialysis, cardiovascular events and central nervous vascular events

Full Information

First Posted
April 28, 2009
Last Updated
December 1, 2009
Sponsor
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00890279
Brief Title
Efficacy and Safety Study of Second-Line Treatment for Hypertension With Autosomal Dominant Polycystic Kidney Disease(ADPKD)
Official Title
Phase II Study for the Second-Line Treatment of Hypertension in Patients With Autosomal Dominant Polycystic Kidney Disease; ACEI vs. CCB
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cilnidipine
Arm Type
Experimental
Arm Description
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.
Arm Title
Imidapril
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cilnidipine
Other Intervention Name(s)
ATELEC
Intervention Description
Cilnidipine up to 20 mg
Intervention Type
Drug
Intervention Name(s)
Imidapril
Other Intervention Name(s)
TANATRIL
Intervention Description
Imidapril up to 10 mg per day
Primary Outcome Measure Information:
Title
eGFR
Time Frame
every 6 months
Secondary Outcome Measure Information:
Title
Kidney Volume measured by MRI
Time Frame
every 3 months to every 2 years
Title
Serum creatinine level
Time Frame
every 3 months to every 2 years
Title
Induction of hemodialysis, cardiovascular events and central nervous vascular events
Time Frame
every 3 months to every 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shigeo Horie, MD
Phone
+81339642497
Email
shorie@med.teikyo-u.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Satoru Muto, MD, PhD
Phone
+81339642497
Email
muto@med.teikyo-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigeo Horie, MD
Organizational Affiliation
Teikyo University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Medicine II, Hokkaido Univserity School of Medicine
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
0608638
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshio Mochizuki, MD
Phone
+81117065915
Email
mtoshi@med.hokudai.ac.jp
First Name & Middle Initial & Last Name & Degree
Toshio Mochizuki, MD
Facility Name
Toranomon Hospital Kajigaya, Kidney center
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihumi Ubara, MD
Phone
+81448775111
Ext
6064
Email
ubara@toranomon.gr.jp
First Name & Middle Initial & Last Name & Degree
Yoshihumi Ubara, MD
Facility Name
Department of Medicine II, Nippon Medical School
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138602
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuhiko Iino, MD
Phone
+81338222131
Email
iinoyasuhiko@nms.ac.jp
First Name & Middle Initial & Last Name & Degree
Yasuhiko Iino, MD
Facility Name
Department of Urology, Teikyo University School of Medicine
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
1738605
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeo Horie, MD
Phone
+81339642497
Email
shorie@med.teikyo-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Satoru Muto, MD
Phone
+81339642497
Email
muto@med.teikyo-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Shigeo Horie, MD
Facility Name
Toranomon Hospital, Kidney center
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenmei Takaichi, MD
Phone
+81335881111
Ext
7065
Email
takaichi@toranomon.gr.jp
First Name & Middle Initial & Last Name & Degree
Kenmei Takaichi, MD
Facility Name
Division of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058471
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Department of Urology, Kyorin University School of Medicine
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
1818611
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eiji HIgashihara, MD
Phone
81422475511
Email
ehigashi@kyorin-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Kikuo Nutahara, MD
Phone
81422475511
Email
kinuta@kyorin-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Eiji Higashihara, MD
First Name & Middle Initial & Last Name & Degree
Kikuo Nutahara, MD
Facility Name
Department of Urology, National Hospital Organaization Chiba-East Hospital
City
Chiba
ZIP/Postal Code
2608712
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koichi Kamura, MD
Phone
+81432615171
Ext
7607
Email
kamura@cehpnet.com
First Name & Middle Initial & Last Name & Degree
Koichi Kamura, MD
Facility Name
Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences
City
Niigata
ZIP/Postal Code
9518510
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ichiei Narita, MD
Phone
+813252272193
Email
naritai@med.niigata-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Ichiei Narita, MD

12. IPD Sharing Statement

Learn more about this trial

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

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