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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00890279

Enrollment

160

Registered

2009-04-29

Start date

2009-07-31

Completion date

2012-11-30

Last updated

2009-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGCilnidipine

Cilnidipine up to 20 mg

DRUGImidapril

Imidapril up to 10 mg per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
eGFR	every 6 months

Secondary

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

Countries

Japan

Contacts

Primary ContactShigeo Horie, MD

shorie@med.teikyo-u.ac.jp+81339642497

Backup ContactSatoru Muto, MD, PhD

muto@med.teikyo-u.ac.jp+81339642497

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026