Chronic Kidney DiseaseNCT02208674
Early Identification and Action in CKD
A study testing Protocolized, pharmacist-delivered CKD Action Plan in people with Chronic Kidney Disease and Hypertension, run by Geisinger Clinic at 1 site in United States.
Trial summary
Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and hypertension will reduce these risks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- Protocolized, pharmacist-delivered CKD Action Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2016
- 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
- 18 years of age or older
- eGFRCR value between 45-59 ml/min/1.73m2 in the prior 12 months
- scheduled laboratory appointment for serum creatinine testing within the next 30 days
- average systolic or diastolic blood pressure reading of at least 150 or 85 mm Hg, respectively, during the prior 12 months.
Who cannot join
- fewer than 2 blood pressure readings in the prior 12 months,
- pregnancy
- current hospitalization
- life expectancy less than 6 months as determined by the study investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is screened and treated according to recommended guidelines. Using a cluster-randomized, controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize 6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a pharmacist-directed "CKD Action Plan" (group 2). Determining the impact of the CKD Action Plan on screening and treatment guideline adherence is the primary goal of this pilot study.
- Conditions
- Chronic Kidney Disease, Hypertension
- Being tested
- Protocolized, pharmacist-delivered CKD Action Plan
- Keywords
- chronic kidney disease, albuminuria, hypertension, dyslipidemia, cardiovascular disease, pragmatic trial, cluster randomized trial
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Albuminuria, Dyslipidemias, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolized, pharmacist-delivered CKD Action PlanOther
Also called Health care delivery procedure
The CKD Action plan protocolizes the screening and treatment of primary risk factors for CKD progression and cardiovascular disease among individuals with stage G3A CKD
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care. |
| Protocolized, pharmacist-delivered CKD Action Plan | Experimental | Protocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations. Receives: Other: Protocolized, pharmacist-delivered CKD Action Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Urinary Albumin Excretion
Completed test for urine albumin/creatinine (or urine protein/creatinine)
Measured: At 12 months
Secondary outcomes (10)
Dyslipidemia Screening
One-time test for dyslipidemia (lipid panel)
Measured: At least once after eGFR < 60 ml/min
ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic)
Measured: within 12 months of enrollment date
Statin Treatment
If age >= 50
Measured: Within 12 months of enrollment
Blood Pressure Control-1
Measured: Average of last two readings prior to 12 months post-enrollment
Blood Pressure--II
Measured: Average of all blood pressures within 12 month study period
Blood Pressure--III
Target blood pressure attained (using KDIGO criteria) based on average of last 2 clinic readings within 12 month study period
Measured: at 12 months post enrollment
Biochemical Surveillance
Test order for serum creatinine, potassium, and sodium within two weeks of ACEI or ARB initiation or titration.
Measured: two weeks after initiation or titration of ACEI or ARB
Symptomatic Adverse Drug Event
Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug
Measured: At 12 months post-enrollment
Patient and Provider Satisfaction
Based on administered surveys
Measured: 9-12 months post study start date
Cystatin C Supplementary Screening
One-time serum cystatin C test for individuals with eGFR between 45 and 59 ml/min and urine albumin-creatinine < 30 mg/g.
Measured: within 12 months of enrollment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
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 Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Chang, Geisinger Clinic
- Investigators
- Alex Chang, MD, MS, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208674
- Sponsor's protocol ID
- 2014-0251
- Status last verified
- Nov 2016
- First submitted
- 1 Aug 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data for this study may be obtained upon request, after permission to do so is granted by the Geisinger IRB and information security office. Readers should contact the principal investigator (achang@geisinger.edu) for further information.
Publications
Chang AR, Evans M, Yule C, Bohn L, Young A, Lewis M, Graboski E, Gerdy B, Ehmann W, Brady J, Lawrence L, Antunes N, Green J, Snyder S, Kirchner HL, Grams M, Perkins R. Using pharmacists to improve risk stratification and management of stage 3A chronic kidney disease: a feasibility study. BMC Nephrol. 2016 Nov 8;17(1):168. doi: 10.1186/s12882-016-0383-7.
PubMed 27825313
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Action in CKD
- ClinicalTrials.gov ID
- NCT02208674
- Acronym / sponsor ID
- 2014-0251
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- chronic kidney disease, albuminuria, hypertension, dyslipidemia, cardiovascular disease, pragmatic trial, cluster randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 5 Aug 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.
Chronic kidney disease (CKD) is highly prevalent and associated with significantly increased risk of cardiovascular morbidity and end-stage renal disease. Evidence from randomized clinical trials suggests that treating urinary albumin excretion (UAE), dyslipidemia, and hypertension will reduce these risks. Unfortunately, less than 30% of the CKD population is screened and treated according to recommended guidelines. Using a cluster-randomized, controlled design and clinic-embedded pharmacists, this pilot pragmatic trial will randomize 6 Geisinger primary care clinics (72 patients) to usual care (group 1) or a pharmacist-directed "CKD Action Plan" (group 2). Determining the impact of the CKD Action Plan on screening and treatment guideline adherence is the primary goal of this pilot study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Primary care provider-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per usual care. |
| Protocolized, pharmacist-delivered CKD Action Plan | Experimental | Other: Protocolized, pharmacist-delivered CKD Action PlanProtocolized, pharmacist-delivered screening and treatment for risk factors (hypertension, albuminuria, dyslipidemia) per KDIGO and JNC-8 recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- eGFRCR value between 45-59 ml/min/1.73m2 in the prior 12 months
- scheduled laboratory appointment for serum creatinine testing within the next 30 days
- average systolic or diastolic blood pressure reading of at least 150 or 85 mm Hg, respectively, during the prior 12 months.
Key exclusion criteria (4 listed)
- fewer than 2 blood pressure readings in the prior 12 months,
- pregnancy
- current hospitalization
- life expectancy less than 6 months as determined by the study investigators
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 |
|---|---|---|
| Protocolized, pharmacist-delivered CKD Action PlanAlso: Health care delivery procedureThe CKD Action plan protocolizes the screening and treatment of primary risk factors for CKD progression and cardiovascular disease among individuals with stage G3A CKD | Other | Protocolized, pharmacist-delivered CKD Action Plan |
Primary outcome
Screening Urinary Albumin Excretion
Time frame: At 12 months
Completed test for urine albumin/creatinine (or urine protein/creatinine)
10 secondary outcomes
Dyslipidemia Screening
Time frame: At least once after eGFR < 60 ml/min
ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic)
Time frame: within 12 months of enrollment date
Statin Treatment
Time frame: Within 12 months of enrollment
Blood Pressure Control-1
Time frame: Average of last two readings prior to 12 months post-enrollment
Blood Pressure--II
Time frame: Average of all blood pressures within 12 month study period
Blood Pressure--III
Time frame: at 12 months post enrollment
Biochemical Surveillance
Time frame: two weeks after initiation or titration of ACEI or ARB
Symptomatic Adverse Drug Event
Time frame: At 12 months post-enrollment
Patient and Provider Satisfaction
Time frame: 9-12 months post study start date
Cystatin C Supplementary Screening
Time frame: within 12 months of enrollment date
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 15 Nov 2016.
- Background: PubMed 27825313Chang AR, Evans M, Yule C, Bohn L, Young A, Lewis M, Graboski E, Gerdy B, Ehmann W, Brady J, Lawrence L, Antunes N, Green J, Snyder S, Kirchner HL, Grams M, Perkins R. Using pharmacists to improve risk stratification and management of stage 3A chronic kidney disease: a feasibility study. BMC Nephrol. 2016 Nov 8;17(1):168. doi: 10.1186/s12882-016-0383-7.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data for this study may be obtained upon request, after permission to do so is granted by the Geisinger IRB and information security office. Readers should contact the principal investigator (achang@geisinger.edu) for further information.
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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.
Alex Chang, MD, MS principal investigator
Geisinger 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 Protocolized, pharmacist-delivered CKD Action Plan in people with Chronic Kidney Disease and Hypertension, run by Geisinger 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 4 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 15 Nov 2016. 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?
Screening Urinary Albumin Excretion (time frame: At 12 months). 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 NCT02208674, 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 15 Nov 2016.