Chronic Kidney DiseaseCKDNCT01792661
Navigating the Challenges of Chronic Kidney Disease
A study testing Enhanced MyChart, Patient Navigator and MyChart in people with Chronic Kidney Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The study's purpose is to address the challenges of providing stage-appropriate chronic kidney disease (CKD) education and care by developing innovative programs using a CKD Patient Navigator system and an EHR (electronic health record)-based enhanced electronic communication system specific for a CKD patient and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Enhanced MyChart, Patient Navigator and MyChart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- English speaking
- eGFR 15-45 ml/min
- patients residing in North East Ohio
Who cannot join
- mentally incompetent
- cancer
- terminal illness
- patients on dialysis
- patients who have had renal transplant.
Trial locations and contacts
1 site in 1 country.
About this study
The study's purpose is to address the challenges of providing stage-appropriate chronic kidney disease (CKD) education and care by developing innovative programs using a CKD Patient Navigator system and an EHR (electronic health record)-based enhanced electronic communication system specific for a CKD patient and her/his physicians/caregivers. The investigators plan a randomized controlled trial of these innovations to examine the utility and effectiveness of these special interventions.
The investigators' CKD registry aids in identifying patients for recruitment for the randomized control trial. Patients are randomized into one of four groups. The four groups are: 1) the control group using MyChart; 2) an enhanced personal health record (PHR) included in MyChart consisting of 35 websites chosen to disseminate CKD stage-specific goals of care and CKD education; 3) the patient navigator, a lay professional trained in the specifics of chronic kidney disease navigation with a focus on the needs of their patients based on the National Kidney Foundation Disease Outcomes Quality Initiative; 4) the patient navigator combined with the enhanced MyChart.
Read more
The investigators hypothesize that a CKD Patient Navigator program will develop a more prepared, proactive patient-caregiver team than usual care; the enhanced PHR will produce a more informed, engaged patient than usual care; the CKD Patient Navigator arm and enhanced PHR will demonstrate a slower rate of decline in eGFR (glomerular filtration rate) than usual care.
The results of this study will lay the foundation for a larger multi-center national clinical trial that will build upon the feasibility and knowledge gained from this planning grant.
Read the detailed description
The overall goal of this research is to assess the effects of innovative interventions for CKD on the decline in renal function among patients with CKD stages 3b or 4. First, a CKD Patient Navigator program was created, adapted from the use of Patient Navigators successfully in oncology. Second, an enhanced PHR was developed that uses electronic communication to disseminate CKD stage-specific goals of care and CKD education. Third, a randomized controlled trial is being conducted using a factorial design to investigate the clinical impact and cost-effectiveness of the two interventions - a CKD Patient Navigator and enhanced PHR compared to usual care for CKD Stage 3b/4 patients.
As a conceptual framework for the proposed study, the investigators are using the Chronic Care Model developed by Edward H. Wagner, M.D., Director of The MacColl Institute for Healthcare Innovation, Director of The Robert Wood Johnson Foundation national program "Improving Chronic Illness Care" and Senior Investigator at the Group Health Research Institute in Seattle. The model emphasizes a synergy between community, the health care system, technology and personal interactions to achieve optimal functional and clinical outcomes among people with chronic diseases. It has been adopted by the National Kidney Disease Education Program (NKDEP) to achieve many of their goals related to kidney disease.
With the help of the CKD registry, the investigators are recruiting patients from outpatient clinics at main campus and family health centers located in the surrounding Cleveland area. Patients are being recruited by a trained study coordinator. All patients are informed about study procedures and the purpose of the research, verbally and in a written informed consent document, two copies of which must be signed by both the patient and the study coordinator before enrollment. Upon enrollment, the patients will be provided with a $25 stipend.
The investigators identify from the CKD Registry and recruit eligible patients with CKD stage 3b (eGFR 30-44 ml/min/1.73 m2) or Stage 4 (eGFR 15-29 ml/min/1.73 m2) who meet the inclusion/exclusion criteria. The majority of data comes from the EHR derived CKD registry. The investigators obtain baseline demographic characteristics (age, gender, and race), comorbidities, and medication use, smoking status at the baseline visit. Further, CKD stage specific laboratory data will be collected routinely i.e., whether a laboratory parameter was measured or not and if measured, whether the laboratory measures and blood pressure are under the target limits. Details about nephrology, vascular access, and transplant referrals are obtained at baseline visit. The primary outcome of the study will be change in eGFR over the two-year study period.
- Conditions
- Chronic Kidney Disease
- Being tested
- Enhanced MyChart, Patient Navigator, MyChart
- Keywords
- Chronic Kidney Disease, Electronic Health Record, Personal Health Record, Chronic Kidney Disease registry, Glomerular Filtration Rate, Patient Navigator
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced MyChartOther
Also called CKD Enhanced PHR
Subjects randomized into the MyChart receive an additional site on their MyChart containing 35 extra educational links specific to CKD, targetting care for stage 3b and stage 4 patients.
Patient NavigatorOther
The Patient Navigator aids subjects in education of their CKD, timely scheduling of appointments, plus determining and overcoming barriers to their CKD health care. The Patient Navigator's job is not part of routine medical care.
MyChartOther
Sign-up to MyChart is optional for Cleveland Clinic patients. Subjects enrolled into the study are signed-up for MyChart (if not already signed-up) during the consenting process.
| Study group | Role | What they receive |
|---|---|---|
| MyChart | Active comparator | The control group receives standard Cleveland Clinic care and has access to MyChart which is the standard Cleveland Clinic electronic PHR. Receives: Other: MyChart |
| Enhanced MyChart | Active comparator | The enhanced PHR functionality adds the ability to securely receive and review CKD-education related messages to the existing features available to all PHR users. The CKD-educational related messages can be automatically delivered at pre-defined intervals and customized for each individual patient at their discretion and convenience. Receives: Other: Enhanced MyChart |
| Patient Navigator | Active comparator | A tracking log is kept by the Patient Navigator of each interaction regarding type of encounter, length of encounter, barriers addressed, and actions that occurred, adapting what is in use for the NIH-funded Patient Navigator program. Receives: Other: Patient Navigator; Other: MyChart |
| Patient Navigator and Enhanced MyChart | Active comparator | Combines patient self empowerment, regarding their CKD, with the Enhanced MyChart along with the aid and direction of a Patient Navigator. Receives: Other: Enhanced MyChart; Other: Patient Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Renal Function
CKD stage specific laboratory data is being collected quarterly. Most of the data will come from the CKD registry, supplemented by the data collection system from the EHR set up by the Cleveland Clinic Department of Quantitative Health Sciences (QHS).
Lab and urine measures are: eGFR, urine albumin to creatinine ratio, parathyroid hormone, 25-OH vitamin D, low density lipoprotein, hemoglobin, calcium and phosphorus.
Clinical targets are: blood pressure, LDL, 25-OH Vitaming D. Preparation for possible transition to End Stage Renal Disease (ESRD): Nephrology referral, vascular access referral, transplant referral.
Whether renoprotective medications are prescribed, such as ACEi and ARB.
Measured: baseline and 1 year
Secondary outcomes (1)
CKD Knowledge and Awareness
CKD education is being measured with electronic clicks the number of times NKDEP patient education materials are accessed through Enhanced MyChart, NKF pre-ESRD curriculum.
Similarly, the frequency of MyChart access of laboratory results and appointments specific to CKD awareness, Nephrology, CKD Clinic, Primary Care Physician, is being measured.
Nutrition is also being similarly measured; NKDEP nutrition patient education materials, nutrition referral.
Patient Navigator contact frequency and subsequent patient follow-up of laboratory work and medical appointments are the indicators of patient willingness to increase their CKD knowledge.
Measured: baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2012
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Nally, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792661
- Sponsor's protocol ID
- 12-072
- Other IDs
- R34DK094112-01
- Acronym
- CKD
- Status last verified
- May 2021
- First submitted
- 12 Feb 2013
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Navaneethan SD, Jolly SE, Schold JD, Arrigain S, Saupe W, Sharp J, Lyons J, Simon JF, Schreiber MJ Jr, Jain A, Nally JV Jr. Development and validation of an electronic health record-based chronic kidney disease registry. Clin J Am Soc Nephrol. 2011 Jan;6(1):40-9. doi: 10.2215/CJN.04230510. Epub 2010 Nov 4.
PubMed 21051745Navaneethan SD, Kandula P, Jeevanantham V, Nally JV Jr, Liebman SE. Referral patterns of primary care physicians for chronic kidney disease in general population and geriatric patients. Clin Nephrol. 2010 Apr;73(4):260-7. doi: 10.5414/cnp73260.
PubMed 20353733Jolly SE, Burrows NR, Chen SC, Li S, Jurkovitz CT, Narva AS, Norris KC, Shlipak MG. Racial and ethnic differences in albuminuria in individuals with estimated GFR greater than 60 mL/min/1.73 m(2): results from the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2010 Mar;55(3 Suppl 2):S15-22. doi: 10.1053/j.ajkd.2009.09.034.
PubMed 20172444Tonelli M, Muntner P, Lloyd A, Manns BJ, James MT, Klarenbach S, Quinn RR, Wiebe N, Hemmelgarn BR; Alberta Kidney Disease Network. Using proteinuria and estimated glomerular filtration rate to classify risk in patients with chronic kidney disease: a cohort study. Ann Intern Med. 2011 Jan 4;154(1):12-21. doi: 10.7326/0003-4819-154-1-201101040-00003.
PubMed 21200034Chronic Kidney Disease Prognosis Consortium; Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J, Gansevoort RT. Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis. Lancet. 2010 Jun 12;375(9731):2073-81. doi: 10.1016/S0140-6736(10)60674-5. Epub 2010 May 17.
PubMed 20483451Freeman HP. Patient navigation: a community centered approach to reducing cancer mortality. J Cancer Educ. 2006 Spring;21(1 Suppl):S11-4. doi: 10.1207/s15430154jce2101s_4.
PubMed 17020496Freund KM. Patient navigation: the promise to reduce health disparities. J Gen Intern Med. 2011 Feb;26(2):110-2. doi: 10.1007/s11606-010-1593-5. No abstract available.
PubMed 21161422
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating the Challenges of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01792661
- Acronym / sponsor ID
- CKD / 12-072
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Electronic Health Record, Personal Health Record, Chronic Kidney Disease registry, Glomerular Filtration Rate, Patient Navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Feb 2013 (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 study's purpose is to address the challenges of providing stage-appropriate chronic kidney disease (CKD) education and care by developing innovative programs using a CKD Patient Navigator system and an EHR (electronic health record)-based enhanced electronic communication system specific for a CKD patient and her/his physicians/caregivers. The investigators plan a randomized controlled trial of these innovations to examine the utility and effectiveness of these special interventions.
The investigators' CKD registry aids in identifying patients for recruitment for the randomized control trial. Patients are randomized into one of four groups. The four groups are: 1) the control group using MyChart; 2) an enhanced personal health record (PHR) included in MyChart consisting of 35 websites chosen to disseminate CKD stage-specific goals of care and CKD education; 3) the patient navigator, a lay professional trained in the specifics of chronic kidney disease navigation with a focus on the needs of their patients based on the National Kidney Foundation Disease Outcomes Quality Initiative; 4) the patient navigator combined with the enhanced MyChart.
The investigators hypothesize that a CKD Patient Navigator program will develop a more prepared, proactive patient-caregiver team than usual care; the enhanced PHR will produce a more informed, engaged patient than usual care; the CKD Patient Navigator arm and enhanced PHR will demonstrate a slower rate of decline in eGFR (glomerular filtration rate) than usual care.
The results of this study will lay the foundation for a larger multi-center national clinical trial that will build upon the feasibility and knowledge gained from this planning grant.
Detailed description
The overall goal of this research is to assess the effects of innovative interventions for CKD on the decline in renal function among patients with CKD stages 3b or 4. First, a CKD Patient Navigator program was created, adapted from the use of Patient Navigators successfully in oncology. Second, an enhanced PHR was developed that uses electronic communication to disseminate CKD stage-specific goals of care and CKD education. Third, a randomized controlled trial is being conducted using a factorial design to investigate the clinical impact and cost-effectiveness of the two interventions - a CKD Patient Navigator and enhanced PHR compared to usual care for CKD Stage 3b/4 patients.
As a conceptual framework for the proposed study, the investigators are using the Chronic Care Model developed by Edward H. Wagner, M.D., Director of The MacColl Institute for Healthcare Innovation, Director of The Robert Wood Johnson Foundation national program "Improving Chronic Illness Care" and Senior Investigator at the Group Health Research Institute in Seattle. The model emphasizes a synergy between community, the health care system, technology and personal interactions to achieve optimal functional and clinical outcomes among people with chronic diseases. It has been adopted by the National Kidney Disease Education Program (NKDEP) to achieve many of their goals related to kidney disease.
With the help of the CKD registry, the investigators are recruiting patients from outpatient clinics at main campus and family health centers located in the surrounding Cleveland area. Patients are being recruited by a trained study coordinator. All patients are informed about study procedures and the purpose of the research, verbally and in a written informed consent document, two copies of which must be signed by both the patient and the study coordinator before enrollment. Upon enrollment, the patients will be provided with a $25 stipend.
The investigators identify from the CKD Registry and recruit eligible patients with CKD stage 3b (eGFR 30-44 ml/min/1.73 m2) or Stage 4 (eGFR 15-29 ml/min/1.73 m2) who meet the inclusion/exclusion criteria. The majority of data comes from the EHR derived CKD registry. The investigators obtain baseline demographic characteristics (age, gender, and race), comorbidities, and medication use, smoking status at the baseline visit. Further, CKD stage specific laboratory data will be collected routinely i.e., whether a laboratory parameter was measured or not and if measured, whether the laboratory measures and blood pressure are under the target limits. Details about nephrology, vascular access, and transplant referrals are obtained at baseline visit. The primary outcome of the study will be change in eGFR over the two-year study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MyChart | Active comparator | Other: MyChartThe control group receives standard Cleveland Clinic care and has access to MyChart which is the standard Cleveland Clinic electronic PHR. |
| Enhanced MyChart | Active comparator | Other: Enhanced MyChartThe enhanced PHR functionality adds the ability to securely receive and review CKD-education related messages to the existing features available to all PHR users. The CKD-educational related messages can be automatically delivered at pre-defined intervals and customized for each individual patient at their discretion and convenience. |
| Patient Navigator | Active comparator | Other: Patient Navigator, Other: MyChartA tracking log is kept by the Patient Navigator of each interaction regarding type of encounter, length of encounter, barriers addressed, and actions that occurred, adapting what is in use for the NIH-funded Patient Navigator program. |
| Patient Navigator and Enhanced MyChart | Active comparator | Other: Enhanced MyChart, Other: Patient NavigatorCombines patient self empowerment, regarding their CKD, with the Enhanced MyChart along with the aid and direction of a Patient Navigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years
- English speaking
- eGFR 15-45 ml/min
- patients residing in North East Ohio
Key exclusion criteria (5 listed)
- mentally incompetent
- cancer
- terminal illness
- patients on dialysis
- patients who have had renal transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced MyChartAlso: CKD Enhanced PHRSubjects randomized into the MyChart receive an additional site on their MyChart containing 35 extra educational links specific to CKD, targetting care for stage 3b and stage 4 patients. | Other | Enhanced MyChart, Patient Navigator and Enhanced MyChart |
| Patient NavigatorThe Patient Navigator aids subjects in education of their CKD, timely scheduling of appointments, plus determining and overcoming barriers to their CKD health care. The Patient Navigator's job is not part of routine medical care. | Other | Patient Navigator, Patient Navigator and Enhanced MyChart |
| MyChartSign-up to MyChart is optional for Cleveland Clinic patients. Subjects enrolled into the study are signed-up for MyChart (if not already signed-up) during the consenting process. | Other | MyChart, Patient Navigator |
Primary outcome
Change in Renal Function
Time frame: baseline and 1 year
CKD stage specific laboratory data is being collected quarterly. Most of the data will come from the CKD registry, supplemented by the data collection system from the EHR set up by the Cleveland Clinic Department of Quantitative Health Sciences (QHS). Lab and urine measures are: eGFR, urine albumin to creatinine ratio, parathyroid hormone, 25-OH vitamin D, low density lipoprotein, hemoglobin, calcium and phosphorus. Clinical targets are: blood pressure, LDL, 25-OH Vitaming D. Preparation for possible transition to End Stage Renal Disease (ESRD): Nephrology referral, vascular access referral, transplant referral. Whether renoprotective medications are prescribed, such as ACEi and ARB.
1 secondary outcome
CKD Knowledge and Awareness
Time frame: baseline and 1 year
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 21 May 2021.
- Background: PubMed 21051745Navaneethan SD, Jolly SE, Schold JD, Arrigain S, Saupe W, Sharp J, Lyons J, Simon JF, Schreiber MJ Jr, Jain A, Nally JV Jr. Development and validation of an electronic health record-based chronic kidney disease registry. Clin J Am Soc Nephrol. 2011 Jan;6(1):40-9. doi: 10.2215/CJN.04230510. Epub 2010 Nov 4.
- Background: PubMed 20353733Navaneethan SD, Kandula P, Jeevanantham V, Nally JV Jr, Liebman SE. Referral patterns of primary care physicians for chronic kidney disease in general population and geriatric patients. Clin Nephrol. 2010 Apr;73(4):260-7. doi: 10.5414/cnp73260.
- Background: PubMed 20172444Jolly SE, Burrows NR, Chen SC, Li S, Jurkovitz CT, Narva AS, Norris KC, Shlipak MG. Racial and ethnic differences in albuminuria in individuals with estimated GFR greater than 60 mL/min/1.73 m(2): results from the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2010 Mar;55(3 Suppl 2):S15-22. doi: 10.1053/j.ajkd.2009.09.034.
- Background: PubMed 21200034Tonelli M, Muntner P, Lloyd A, Manns BJ, James MT, Klarenbach S, Quinn RR, Wiebe N, Hemmelgarn BR; Alberta Kidney Disease Network. Using proteinuria and estimated glomerular filtration rate to classify risk in patients with chronic kidney disease: a cohort study. Ann Intern Med. 2011 Jan 4;154(1):12-21. doi: 10.7326/0003-4819-154-1-201101040-00003.
- Background: PubMed 20483451Chronic Kidney Disease Prognosis Consortium; Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J, Gansevoort RT. Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis. Lancet. 2010 Jun 12;375(9731):2073-81. doi: 10.1016/S0140-6736(10)60674-5. Epub 2010 May 17.
- Background: PubMed 17020496Freeman HP. Patient navigation: a community centered approach to reducing cancer mortality. J Cancer Educ. 2006 Spring;21(1 Suppl):S11-4. doi: 10.1207/s15430154jce2101s_4.
- Background: PubMed 21161422Freund KM. Patient navigation: the promise to reduce health disparities. J Gen Intern Med. 2011 Feb;26(2):110-2. doi: 10.1007/s11606-010-1593-5. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Joseph Nally, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced MyChart, Patient Navigator and MyChart in people with Chronic Kidney Disease, run by The Cleveland Clinic 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 4 inclusion and 5 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 21 May 2021. 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 Renal Function (time frame: baseline and 1 year). 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 NCT01792661, which also lists 7 linked publications.
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 21 May 2021.