Autosomal Dominant Polycystic Kidney DiseaseNCT02084849
ADPKD Cohort Study
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- How many people
- 624 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1998to May 2015
- How long will I take part?
- 84 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: ADPKD individuals at risk for progression to End Stage Renal Disease (ESRD)
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study
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.
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 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. | |
| Group 2 | Group 2 will consist of ADPKD subjects who have progressed to a more advanced stage of their renal disease. There is no limit with regard to the number of subjects to be recruited into this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GFR as compared to change in renal volume over time
Measured: Three years
Secondary outcomes (1)
Differences in the ability to determine change in renal volume over time between MRI and ultrasound
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startJun 1998
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 624 participants (actual)
- Target duration
- 84 Months
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- PKD Foundation
- Responsible party
- Principal investigator, Arlene Chapman, Emory University
- Investigators
- Arlene Chapman, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084849
- Sponsor's protocol ID
- IRB00041117
- Other IDs
- 0247-1998
- Status last verified
- Jun 2015
- First submitted
- 10 Mar 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study
- ClinicalTrials.gov ID
- NCT02084849
- Acronym / sponsor ID
- IRB00041117
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- PKD Foundation
- Study start
- Jun 1998
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 84 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –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. |
| Group 2 | – | –Group 2 will consist of ADPKD subjects who have progressed to a more advanced stage of their renal disease. There is no limit with regard to the number of subjects to be recruited into this group. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- ADPKD individuals at risk for progression to End Stage Renal Disease (ESRD)
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in GFR as compared to change in renal volume over time
Time frame: Three years
1 secondary outcome
Differences in the ability to determine change in renal volume over time between MRI and ultrasound
Time frame: Three years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene Chapman, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GFR as compared to change in renal volume over time (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.