ADPKD Cohort Study

Related Clinical Trial
IMPEDE-PKD Randomised Placebo-controlled Trial Daily Caloric Restriction in ADPKD To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers and Autosomal Dominant Polycystic Kidney Disease Subjects Establishment of the Human Intestinal and Salivary Microbiota Biobank – Kidney Diseases NOX4 and Related Biomarkers in ADPKD A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD) An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) PErfusioN, OxyGen ConsUmptIon and ENergetics in ADPKD (PENGUIN) PKD Biomarkers Study Sirolimus for Massive Polycystic Liver Wishing to Decrease Aquaresis in ADPKD Patients Treated With a V2Ra; the Effect of Regulating Protein and Salt The German ADPKD Tolvaptan Treatment Registry A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD) Statin Therapy in Patients With Early Stage ADPKD Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD A Phase 2 Trial of the Safety and Efficacy of Bardoxolone Methyl in Patients With Rare Chronic Kidney Diseases – PHOENIX PKD Clinical and Translational Core Study Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function Mesenchymal Stem Cells Transplantation in Patients With Chronic Renal Failure Due to Polycystic Kidney Disease Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease Evaluation of Nephrectomy Specimen for Intracranial Aneurysm Development in ADPKD Lanreotide In Polycystic Kidney Disease Study Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease Dietary Intervention in ADPKD on Tolvaptan High Water Intake in Polycystic Kidney Disease Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 Safety of Lixivaptan in Subjects Previously Treated With Tolvaptan for Autosomal Dominant Polycystic Kidney Disease A Trial of Bardoxolone Methyl in Patients With ADPKD – FALCON Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD Tolvaptan-Octreotide LAR Combination in ADPKD Polycystic Kidney Disease Data Repository ADPKD Patient Registry Use of Low Dose Pioglitazone to Treat Autosomal Dominant Polycystic Kidney Disease ADPKD Cohort Study Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD Canadian Medical Assessment of JINARC™ Outcomes Registry Analysis of Clinical and Molecular Genetic Data Influencing the Evolution and Response to Therapy of ADPKD Patients (Autosomal Dominant Polycystic Kidney Disease) ADPKD Alterations in Hepatic Transporter Function Efficacy Study of Water Drinking on PKD Progression. A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe Somatostatin in Polycystic Kidney: a Long-term Three Year Follow up Study Open-Label Tolvaptan Study in Subjects With ADPKD Effects of Somatostatin on ADPKD Heart Clinical and Molecular Description of PKD1 and PKD2 Mutation Negative Carriers in ADPKD Diet as a Potential Treatment for Autosomal Dominant Polycystic Kidney Disease Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy Effect of the Aquaretic Tolvaptan on Nitric Oxide System Pilot Study of Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Outcome of Autosomal Dominant Polycystic Kidney Disease Patients on Peritoneal Dialysis: a National Retrospective Study Based on Two French Registries (the French Language Peritoneal Dialysis Registry and the French Renal Epidemiology and Information Network). Clinical Implications of DNA Analysis on ADPKD The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease Assessment of Longitudinal Changes in Endothelial Function and Oxidative Stress in Normotensive Patients With ADPKD The Eurocyst Initiative: Building a Network of ADPKD Reference Centers Across Europe Efficacy of Tolvaptan on ADPKD Patients Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001] A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002] Somatostatin In Patients With Autosomal Dominant Polycystic Kidney Disease And Moderate To Severe Renal Insufficiency ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure? Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD) Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan] Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease The ELiSA Study – Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease) New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease Autosomal Dominant Polycystic Kidney Disease Somatic Mutation Biorepository Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD) A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease Repository Study of Autosomal Dominant Polycystic Kidney Disease Sirolimus In Autosomal Dominant Polycystic Kidney Disease And Severe Renal Insufficiency Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease The Safety and Efficacy of Catheter-based Renal Denervation Using the Vessix™ Renal Denervation System in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Patients With Severe Debilitating Pain Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD) 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Brief Title

ADPKD Cohort Study

Official Title

The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study

Brief Summary

      The purpose of this study is to find out if radiology tests of the kidneys as opposed to
      glomerular filtration (GFR) tests (GFR test - a lab test that measures kidney function)
      follow progression of polycystic kidney disease (PKD) the best. PKD patients at risk for
      progression to renal failure (dialysis or transplantation) have been identified and include
      those who have been diagnosed with high blood pressure early, the presence of the PKD1 gene
      (the inherited abnormality responsible for the majority of PKD), men as opposed to women,
      those with episodes of visible blood or increased protein in their urine, and women who have
      experience more than three pregnancies. Individuals who are diagnosed with PKD in the first
      year of life or in utero (before birth) are also at high risk for progression to renal
      failure.

      This study will also facilitate understanding of human diseases at the cellular and molecular
      level. We will be identifying genetic factors that may influence the severity of polycystic
      kidney disease (PKD). You are being asked to provide a sample of blood for the purpose of DNA
      or other biochemical analyses.
    



Study Type

Observational [Patient Registry]


Primary Outcome

Change in GFR as compared to change in renal volume over time

Secondary Outcome

 Differences in the ability to determine change in renal volume over time between MRI and ultrasound

Condition

Autosomal Dominant Polycystic Kidney Disease


Study Arms / Comparison Groups

 Group 1
Description:  Group 1 will consist of 300 ADPKD individuals who are early in the course of their disease and demonstrate risk factors for progression to ESRD.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

624

Start Date

June 1998

Completion Date

May 2015

Primary Completion Date

May 2015

Eligibility Criteria

        Inclusion Criteria:

        Group 1

          -  Hypertension diagnosed early in the course of the disease (less than 25 years for men;
             less than 30 years for women)

          -  ADPKD diagnosed in utero or in the first year of life

          -  The presence of proteinuria (between 180 mg and 1 gm/day) without evidence of a second
             renal disorder

          -  A history of more than 3 pregnancies and hypertension

          -  A history of gross hematuria

          -  A serum creatinine concentration less than 1.4 mg/dl

          -  ADPKD diagnosed in childhood with more than 10 cysts

        Group 2

          -  Serum creatinine concentration >1.4 and

          -  Renal length greater than 15 cm and

          -  Age less than 60 years of age

          -  Severe pain or discomfort as assessed by the primary care physician related to ADPKD

        Exclusion Criteria:

          -  Subjects, who in the assessment of the principal investigator cannot provide reliable
             follow-up

          -  Subjects who cannot be exposed to iothalamate

          -  Subjects who cannot undergo MRI due to the presence of a pacemaker or surgical clip in
             the abdomen

          -  Subjects who are not anticipated to survive during the duration of the study (e.g.
             underlying malignancy)

          -  Subjects who cannot provide informed consent

          -  Women who are pregnant or who have undergone a pregnancy in the last 6 months or who
             are presently breastfeeding
      

Gender

All

Ages

N/A - 60 Years

Accepts Healthy Volunteers

No

Contacts

Arlene Chapman, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02084849

Organization ID

IRB00041117

Secondary IDs

0247-1998

Responsible Party

Principal Investigator

Study Sponsor

Emory University

Collaborators

 PKD Foundation

Study Sponsor

Arlene Chapman, MD, Principal Investigator, Emory University


Verification Date

June 2015