Intervention Arm for Kidney Diseases

Phase-Based Estimates
1
Effectiveness
1
Safety
UPMC Presbyterian, Pittsburgh, PA
Kidney Diseases+2 More
Intervention Arm - Other
Eligibility
18+
All Sexes
Eligible conditions
Kidney Diseases

Study Summary

This study is evaluating whether a set of activities can improve care for people with chronic kidney disease.

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Eligible Conditions

  • Kidney Diseases
  • Chronic Kidney Diseases
  • Chronic Kidney Disease (CKD)
  • Renal Insufficiency, Chronic

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Intervention Arm will improve 1 primary outcome, 8 secondary outcomes, and 3 other outcomes in patients with Kidney Diseases. Measurement will happen over the course of Through study completion, an average of 24 months.

Month 24
Composite medication safety: Inappropriate use of Non-Steroidal Anti-inflammatory Drugs (NSAIDs), glyburide, metformin, gemfibrozil, sodium glucose cotransporter 2 (SGLT2) inhibitors
Decline in estimated Glomerular Filtration Rate (eGFR) or End Stage Renal Disease (ESRD)
Hypertension (HTN) Control
Medication Safety: Use of Metformin
Medication Safety: Use of SGLT2 inhibitors
Medication Safety: Use of gemfibrozil
Medication Safety: Use of glyburide
Medication safety: Use of Non-Steroidal Anti-inflammatory Drugs (NSAIDS)
Subgroup analysis hypertension (HTN) control (outcome 2) in participants with uncontrolled BP at baseline (i.e., BP >130/80 at baseline).
Subgroup analysis of composite medication safety (outcome 4) in the subgroup of participants receiving at least 1 of the following medications inappropriately at study enrollment: NSAIDs, glyburide, metformin, gemfibrozil, SGLT2 inhibitors
Subgroup analysis: Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi) (outcome 3) in participants who are baseline non-users of RAASi
Use of Renin-Angiotensin-Aldosterone System inhibitors (RAASi)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Usual care
Intervention Arm

This trial requires 1650 total participants across 2 different treatment groups

This trial involves 2 different treatments. Intervention Arm is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention Arm
Other
Patients will receive a care bundle
Usual care
Other
Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 24 months for reporting.

Who is running the study

Principal Investigator
M. J.
Prof. Manisha Jhamb, Assistant Professor
University of Pittsburgh

Closest Location

UPMC Presbyterian - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
most recent eGFR less than 60 ml/min/yr
established care with UPMC PCP
Inclusion criteria for PCPs: presence of an ambulatory continuity clinic in the University of Pittsburgh Medical Center (UPMC) community medicine practice.
age greater than or equal to 18, and less than or equal to 85
high risk CKD based on validated external and internal risk prediction models or severe reduction in eGFR, or substantial loss in eGFR in prior 18 months.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has intervention arm proven to be more effective than a placebo?

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Interventions are effective in delaying or reversing the decline in kidney function. Intervention is more effective than a placebo. This trial can be considered a'real world' situation with a group of subjects (N=32) who have not been receiving care for at least 3.5 years prior to the study start.

Unverified Answer

Does intervention arm improve quality of life for those with kidney diseases?

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No evidence of benefit as measured by any clinical outcome was identified for any or all arm as a whole or as a subset of the participants.

Unverified Answer

How many people get kidney diseases a year in the United States?

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We estimate that 10.7 million Americans have kidney disease, and 9.1 million (83%) of them have it for at least 3 years. This high prevalence could be the result of higher prevalence of underlying kidney disease than currently recognized. The high kidney disease prevalence may also be linked to kidney disease's role as a major cause of death among veterans of the Vietnam War.

Unverified Answer

What are the signs of kidney diseases?

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The signs of kidney diseases in a patient that have been examined at a center of nephrology should be included, except for anemia and leukocytosis, because those were found to be indicative of acute kidney injury due to sepsis, sepsis of the kidney, and nephrotic syndrome of the kidney in the hospital. Although electrolyte levels differed among the groups, the serum creatinine levels were only slightly lower in patients having glomerular or interstitial nephritis.

Unverified Answer

What causes kidney diseases?

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The risk factors for most kidney diseases are multiple and complex, and a simple list of them cannot describe what drives them. The prevention of progression and deterioration of diseases with known risk factors is likely to require a variety of strategies, to be tailored to the individual patient.

Unverified Answer

Can kidney diseases be cured?

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Even kidney diseases that are highly chronic (e.g., chronic kidney disease-minimally amenable to kidney function restoration-and CKD-minimally amenable to kidney function restoration-and CKD-even with renal failure) can mostly and easily be cureable, mostly due to their highly predictable progression to end-stage renal disease, with a one-year mortality rate of about 25% and a five-year mortality rate of about 50%, and only in very few percent cases of less advanced disease do they still remain an incurable disease.

Unverified Answer

What is kidney diseases?

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Kidney diseases are one of the most prevalent multisystem diseases. The number of new cases of kidney disorders in USA have declined the past 20 years because of the improving socioeconomic status and the availability of modern diagnostic tools.

Unverified Answer

What are common treatments for kidney diseases?

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A variety of medications are used for specific diseases. There is no cure to kidney disease. Treatment is aimed at the specific disease and/or symptoms rather than the kidney function. People should consider all factors in choosing a treatment.

Unverified Answer

How serious can kidney diseases be?

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Significant correlations between PES and RPN scores are clearly observed, suggesting that CKD prevalence has increased over time. Findings from a recent study have important implications to health policy makers and primary care clinicians who may consider improving their strategies on prevention for CKD.

Unverified Answer

Is intervention arm safe for people?

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The risk of adverse events associated with treatment is low. The risk of death from any cause is low and does not change with intervention. All treatments were generally acceptable to patients; however, it is important to consider individual preferences in light of the risks, benefits, and resources of the treatments. A prospective study, and future trials are needed to show the true difference and cost-effectiveness of various treatment options.

Unverified Answer

Have there been other clinical trials involving intervention arm?

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Clinically and/or therapeutically relevant outcome measures were not reported by a substantial number of clinical trials comparing interventions. This could reflect lack of knowledge on the part of investigators, a failure to publish results of clinical interventions, or a lack of reported clinical outcomes by publishers. However, reporting of clinical outcomes, where reported, is often in progress.

Unverified Answer

What are the common side effects of intervention arm?

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The common side effects that appear in one study and not in another cannot be explained by variations in the interventions administered, demographics of the patient group, study protocol, [experimental group, placebo group, and power(http://www.withpower.com/clinical-trials/triple-negativity-breast-cancer) are the three main factors that affect the side effects to a high degree.

Unverified Answer
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