Autosomal Dominant Polycystic Kidney DiseaseCRISP IINCT01039987
Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease
An observational study of Autosomal Dominant Polycystic Kidney Disease, run by University of Pittsburgh at 5 sites in United States.
Trial summary
The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a consortium of participating clinical centers (PCCs) and a data coordinating and imaging analysis center (DCIAC) to develop and… Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- How many people
- 211 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 1999to Mar 2011
- 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 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants who are diagnosed with ADPKD between the ages of 15 and 45 with risk factors (2/3 of the study population) or without risk factors (1/3 of the study population)for progression to ESRD with relatively normal renal function were be eligible for recruitment into the CRISP I study. The objective of the recruitment process was to identify ADPKD participants with the appropriate level of renal function who are either at high or low risk for progression to ESRD, who will be available for the entire follow-up period and who are likely to be compliant with the study protocols and visit schedules.
Who may be able to join
- 1. CRISP I participants will be invited to participate in CRISP II. At entry into CRISP I participants met a number of inclusion and exclusion criteria.
Who cannot join
- Current psychiatric or addiction or non-compliance disorder that in the discretion of the principal investigator indicates that the subject will not successfully complete the study;
- Current medical problem that in the discretion of the principal investigator would make unsafe the participation in the study;
- Inability to provide written informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama-Birmingham
Birmingham, Alabama, 35294
University of Kansas
Kansas City, Kansas, 66160
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 559005
About this study
Official title: Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II
The Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a consortium of participating clinical centers (PCCs) and a data coordinating and imaging analysis center (DCIAC) to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of progression of renal disease in patients with polycystic kidney disease.
The awarded participating clinical centers are Emory University, University of Kansas, and Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington University to the University of Pittsburgh, the DCIAC for CRISP II is located at the University of Pittsburgh.
Read the detailed description
The goal of the CRISP Study is to conduct a prospective, longitudinal trial to evaluate the accuracy and validity of magnetic resonance imaging to determine disease progression in ADPKD defined as a change in both renal and renal cyst volumes and renal function over time.
- Keywords
- Autosomal dominant polycystic kidney disease, ADPKD, kidney, Biomarker, MRI
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney volume
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 posted25 Dec 2009 (estimated)
- Study startSep 1999
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Kyongtae Ty Bae, M.D., Ph.D., University of Pittsburgh
- Investigators
- Marva Moxey-Mims, M.D., Study director, NIH, NIDDK, DKUHK. Ty BAE, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039987
- Sponsor's protocol ID
- DK056961
- Acronym
- CRISP II
- Status last verified
- Aug 2017
- First submitted
- 23 Dec 2009
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bae K, Park B, Sun H, Wang J, Tao C, Chapman AB, Torres VE, Grantham JJ, Mrug M, Bennett WM, Flessner MF, Landsittel DP, Bae KT; Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP). Segmentation of individual renal cysts from MR images in patients with autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol. 2013 Jul;8(7):1089-97. doi: 10.2215/CJN.10561012. Epub 2013 Mar 21.
PubMed 23520042
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) II
- ClinicalTrials.gov ID
- NCT01039987
- Acronym / sponsor ID
- CRISP II / DK056961
- Keywords
- Autosomal dominant polycystic kidney disease, ADPKD, kidney, Biomarker, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 1999
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Dec 2009 (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 Division of Kidney Urology and Hematology Disease (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) funded a cooperative agreement (UO1) for a consortium of participating clinical centers (PCCs) and a data coordinating and imaging analysis center (DCIAC) to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of progression of renal disease in patients with polycystic kidney disease.
The awarded participating clinical centers are Emory University, University of Kansas, and Mayo Foundation (with a subcontract to the University of Alabama). The awarded DCIAC is Washington University in St. Louis. Due to the relocation of the DCIAC P.I. from Washington University to the University of Pittsburgh, the DCIAC for CRISP II is located at the University of Pittsburgh.
Detailed description
The goal of the CRISP Study is to conduct a prospective, longitudinal trial to evaluate the accuracy and validity of magnetic resonance imaging to determine disease progression in ADPKD defined as a change in both renal and renal cyst volumes and renal function over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants who are diagnosed with ADPKD between the ages of 15 and 45 with risk factors (2/3 of the study population) or without risk factors (1/3 of the study population)for progression to ESRD with relatively normal renal function were be eligible for recruitment into the CRISP I study. The objective of the recruitment process was to identify ADPKD participants with the appropriate level of renal function who are either at high or low risk for progression to ESRD, who will be available for the entire follow-up period and who are likely to be compliant with the study protocols and visit schedules.
Key inclusion criteria (1 listed)
- 1. CRISP I participants will be invited to participate in CRISP II. At entry into CRISP I participants met a number of inclusion and exclusion criteria.
Key exclusion criteria (3 listed)
- Current psychiatric or addiction or non-compliance disorder that in the discretion of the principal investigator indicates that the subject will not successfully complete the study;
- Current medical problem that in the discretion of the principal investigator would make unsafe the participation in the study;
- Inability to provide written 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
kidney volume
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 17 Aug 2017.
- Derived from this study: PubMed 23520042Bae K, Park B, Sun H, Wang J, Tao C, Chapman AB, Torres VE, Grantham JJ, Mrug M, Bennett WM, Flessner MF, Landsittel DP, Bae KT; Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP). Segmentation of individual renal cysts from MR images in patients with autosomal dominant polycystic kidney disease. Clin J Am Soc Nephrol. 2013 Jul;8(7):1089-97. doi: 10.2215/CJN.10561012. Epub 2013 Mar 21.
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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.
Marva Moxey-Mims, M.D. study director
NIH, NIDDK, DKUH
K. Ty BAE, MD, PhD principal investigator
University of Pittsburgh
5 sites 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 University of Pittsburgh at 5 sites 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 1 inclusion and 3 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
kidney volume (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039987, which also lists 1 linked publication.
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 17 Aug 2017.