Clinical Implications of DNA Analysis on ADPKD

NCT ID: NCT02322385

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-12-31

Brief Summary

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Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. We plan DNA analysis using the next generation sequencer (NGS) and examine the relationship between mutational types and clinical phenotypes. The accuracy of DNA analysis with NGS is tested by Sanger's method. The kidney and life survival curves will be compared between PKD1, PKD2 and non-ADPKD family members.

Detailed Description

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80 unrelated patients with ADPKD attending to the Kyorin University Hospital whose clinical data are compiled. DNA analysis is performed at Otsuka Pharmaceutical Laboratory.

Clinical data include total kidney volume (TKV), TKV slope, eGFR, eGFR slope and other clinically relevant data.

Conditions

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Autosomal Dominant Polycystic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* The unrelated patients with ADPKD.

Exclusion Criteria

* The patients whose clinical data are not compiled.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kyorin University

OTHER

Sponsor Role lead

Responsible Party

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Eiji Higashihara, MD

Professor of Department of Polycystic Kidney Research, Kyorin University School of Medicine.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eiji Higashihara, MD

Role: STUDY_CHAIR

Department of Polycystic Kidney Research, Kyorin University School of Medicine

Locations

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Department of Polycystic Kidney Research, Kyorin University School of Medicine

Mitaka, Tokyo, Japan

Site Status

Department of Urology, Kyorin University Hospital

Mitaka, Tokyo, Japan

Site Status

Countries

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Japan

References

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Higashihara E, Horie S, Kinoshita M, Harris PC, Okegawa T, Tanbo M, Hara H, Yamaguchi T, Shigemori K, Kawano H, Miyazaki I, Kaname S, Nutahara K. A potentially crucial role of the PKD1 C-terminal tail in renal prognosis. Clin Exp Nephrol. 2018 Apr;22(2):395-404. doi: 10.1007/s10157-017-1477-7. Epub 2017 Oct 5.

Reference Type DERIVED
PMID: 28983800 (View on PubMed)

Other Identifiers

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Kyorin-PKD-1

Identifier Type: -

Identifier Source: org_study_id

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