Early Identification and Action in CKD

Hypertension Clinical Trial

Official title:

Early Identification and Action in CKD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208674
• Other study ID #: 2014-0251
• Status: Completed
• Phase: N/A
• First received: August 1, 2014
• Last updated: November 14, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Protocolized, pharmacist-delivered CKD Action Plan
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

Locations

Country	Name	City	State
United States	Geisinger Health System	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Screening Urinary Albumin Excretion	Completed test for urine albumin/creatinine (or urine protein/creatinine)	At 12 months	No
Secondary	Dyslipidemia Screening	One-time test for dyslipidemia (lipid panel)	At least once after eGFR < 60 ml/min	No
Secondary	ACEI or ARB Treatment if urine ACR is > 30 mg/g (diabetic) or > 300 mg/g (non-diabetic)		within 12 months of enrollment date	No
Secondary	Statin Treatment	If age >= 50	Within 12 months of enrollment	No
Secondary	Blood Pressure Control-1		Average of last two readings prior to 12 months post-enrollment	No
Secondary	Blood Pressure--II		Average of all blood pressures within 12 month study period	No
Secondary	Blood Pressure--III	Target blood pressure attained (using KDIGO criteria) based on average of last 2 clinic readings within 12 month study period	at 12 months post enrollment	No
Secondary	Biochemical Surveillance	Test order for serum creatinine, potassium, and sodium within two weeks of ACEI or ARB initiation or titration.	two weeks after initiation or titration of ACEI or ARB	Yes
Secondary	Symptomatic Adverse Drug Event	Angioedema, anaphylaxis, syncope, hypotension, or myopathy after initiation or titration of antihypertensive and/or statin drug	At 12 months post-enrollment	Yes
Secondary	Patient and Provider Satisfaction	Based on administered surveys	9-12 months post study start date	No
Secondary	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.	within 12 months of enrollment date	No

External Links

•   Link