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Trial record 3 of 3 for:    "Polycystic Kidney Disease 2 with or Without Polycystic Liver Disease"

Clinical Implications of DNA Analysis on ADPKD (DNAAA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02322385
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Eiji Higashihara, MD, Kyorin University

Tracking Information
First Submitted Date January 24, 2014
First Posted Date December 23, 2014
Last Update Posted Date March 3, 2017
Study Start Date January 2014
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2014)
The relationship between mutational types and phenotypes [ Time Frame: Depends on the observational period at least more than one year. ]
  • Total Kidney Volume (TKV) measured by MRI and its slope.
  • Total Liver Volume (TLV) measured by MRI and its slope.
  • GFR estimated by plasma creatinine and cystatin C (eGFR).
  • Other clinical data, such as QOL scores and ADPKD-related symptoms.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02322385 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 22, 2014)
Identify the efficacy of next generation sequencing method [ Time Frame: One year. ]
  • Compatibility of sequence results between two NGSs.
  • Compatibility of sequence results between NGS and Sanger's method.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 22, 2014)
The relationship between mutational types and phenotypes; [ Time Frame: One year. ]
• The radiologic findings of intracranial aneurysm and cerebral arteries.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Clinical Implications of DNA Analysis on ADPKD
Official Title Mutational Types and Phenotypes Relationship in Autosomal Dominant Polycystic Kidney Disease
Brief Summary 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

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood
Sampling Method Non-Probability Sample
Study Population The patients with ADPKD visiting Kyorin university hospital over two years. The patients whose clinical data including total kidney volume (TKV), eGFR, QOL data and other relevant clinical data are available will be enrolled.
Condition Autosomal Dominant Polycystic Kidney Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 22, 2014)
80
Original Estimated Enrollment Same as current
Actual Study Completion Date December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The unrelated patients with ADPKD.

Exclusion Criteria:

  • The patients whose clinical data are not compiled.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02322385
Other Study ID Numbers Kyorin-PKD-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eiji Higashihara, MD, Kyorin University
Study Sponsor Kyorin University
Collaborators Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Chair: Eiji Higashihara, MD Department of Polycystic Kidney Research, Kyorin University School of Medicine
PRS Account Kyorin University
Verification Date February 2017