Treatment for Kidney Diseases

Phase-Based Estimates
3
Effectiveness
3
Safety
Integrative Physiology of Aging Laboratory, Boulder, CO
Kidney Diseases+2 More
Eligibility
18+
All Sexes
Eligible conditions
Kidney Diseases

Study Summary

This study is evaluating whether a dietary supplement may help improve vascular, motor, and cognitive function in individuals with chronic kidney disease.

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Eligible Conditions

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

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes, 2 secondary outcomes, and 2 other outcomes in patients with Kidney Diseases. Measurement will happen over the course of Baseline, 3 months.

Baseline, 3 months
Change in aortic stiffness
Change in endothelial cell markers of oxidative stress
Change in oxidative stress-associated suppression of endothelial function assessed as the increase in brachial artery flow-mediated dilation following an ascorbic acid infusion
Change in vascular endothelial function
Fluid cognition composite score
Motor function composite score

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Nitrate-rich beetroot juice
Placebo group

This trial requires 92 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Nitrate-rich beetroot juice
DietarySupplement
Daily dose of nitrate-rich beetroot juice (70 mL) for 3 months.
Nitrate-depleted beetroot juice
DietarySupplement
Daily dose of nitrate-depleted beetroot juice (70 mL) for 3 months. The nitrate-depleted beetroot juice is identical in appearance, taste and caloric content to nitrate-rich beetroot juice, but with nitrate removed.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 3 months for reporting.

Who is running the study

Principal Investigator
D. S.
Prof. Douglas Seals, Professor
University of Colorado, Boulder

Closest Location

Integrative Physiology of Aging Laboratory - Boulder, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Albumin > 3.0 g/dL
Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 6 min, climb 10 stairs)
Mini-mental state examination score >21 (rationale: to screen for subjects with major cognitive impairment)
Blood pressure (BP) >100/60 mmHg for past 3 months (rationale: blood pressure below 100/60 mmHg may elevate the normally small risk of hypotension with nitrate supplementation)
Not taking medications that will interfere with administered medications (e.g., sildenafil interacts with nitroglycerin)
Body mass index (BMI) <40 kg/m2 (vascular function measurements can be inaccurate in severely obese patients)
CKD stage II-IV (eGFR using the Modification of Diet in Renal Disease (MDRD) prediction equation 20-90 mL/min/1.73m2; stable renal function in the past 3 months)
Ability to give informed consent
Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-V)

Patient Q&A Section

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

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

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  • "Clinical Trials."\n\nIn 2011 "BMJ" asked clinicians about the usefulness of clinical trials and the extent to which they felt there were issues and recommendations relating to clinical trial reporting. The responses are also reported in the tables here:\n\nThese tables are based on clinical trials reported to The Centers for Medicare and Medicaid Services (CMS) between January 1, 2000 and December 31, 2009. (See ) For the sake of simplicity, information for clinical trials published before 2000 and after 2009 was not examined.
Unverified Answer

What causes kidney diseases?

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The causes of kidney disease are multifactorial in origin, but the majority of kidney diseases are due to a combination of environmental factors and genetic predisposition.

Unverified Answer

What is kidney diseases?

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In a recent survey, the prevalence of kidney diseases in the USA is estimated at about 13% for the 15-65 year age group, with a higher prevalence in men than women (36% vs 11%). Kidney diseases cause major functional and physical limitation in the elderly, costing billions of dollars in medical expenses nationwide. Furthermore, kidney disease related mortality in the US population is 5 times higher than in China despite having roughly one half the population.

Unverified Answer

What are common treatments for kidney diseases?

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The treatments of kidney diseases are highly varying, partly due to differences in pathophysiology, severity of disease, and severity of comorbid conditions. Thus treatment in order to be effective would need to be tailored to the symptoms and underlying pathophysiology of each specific patient. However, some treatments are common for certain indications, such as in chronic kidney disease, and some treatments for specific indications exist, such as blood pressure medication for hypertension.

Unverified Answer

What are the signs of kidney diseases?

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Although the severity of the disease depends on the type of kidney diseases, when renal dysfunction is in progress, it is often reflected peripherally by signs and symptoms such as fatigue and lethargy, weight gain, anemia, anorexia, malaise, and oliguria. Other signs that indicate severe kidney disease are low urine output (oliguria), decreased urine concentration (>100 mOsm/kg), edema, swelling (e.g., ascites, pleural effusion), abnormal visual field, and thrombocytopenia. Although nonspecific signs can be an indication of severe kidney disease, no single symptom can accurately predict the progress of a patient with renal disease.

Unverified Answer

Can kidney diseases be cured?

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Chronic kidney disease is often reversible once treatment is initiated. The rate of remission/cure increases as the underlying disease or disorder is eliminated. The long-term kidney survival is the same as it would be for healthy individuals of the same age.

Unverified Answer

Does treatment improve quality of life for those with kidney diseases?

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Recent findings of this study showed that people with chronic kidney diseases' life quality improved after treatment due to improvements in their body image and self-esteem.

Unverified Answer

What does treatment usually treat?

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Results from a recent clinical trial contribute to a broad literature on the treatment of renal disease, and to clarify some important aspects of treatment for renal diseases. Our analyses provide information on the factors influencing the choice of treatment in the kidney care environment. In particular, our findings contribute to the evidence base for the use of a number of medications used in patients with kidney problems, and demonstrate that treatments for renal disease vary widely from one clinical practice setting to another.

Unverified Answer

What is the latest research for kidney diseases?

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The most recent research shows only marginal evidence regarding some kidney diseases (cancer, acute kidney injury and chronic kidney disease) on which we do not need to draw more conclusions because at this time there is no evidence of a benefit to patients. New data may provide additional indications for initiation of treatment, but more research is still lacking. This information will be helpful in the decision making of clinicians and patients.

Unverified Answer

What are the latest developments in treatment for therapeutic use?

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The current paradigm is that most patients with glomerulonephritis will have a good outcome with current treatments and will eventually not require renal replacement therapy. A newer framework is that the majority of patients with glomerulonephritis will have a poor outcome and that renal replacement therapy will be required in the majority of cases. Clinicians should be aware of this paradigm shift and the changes that are going to play critical roles in the practice of nephrology in the future.

Unverified Answer

What are the common side effects of treatment?

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Most common side effects of rituximab included flu-like illness, fatigue, anemia, and an increased risk of serious infection. Treatment-related side effects were more severe in patients with higher B-cell counts. The incidence of side effects in children was similar to that in adults.

Unverified Answer

How serious can kidney diseases be?

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Kidney diseases should be taken into account, and proper disease management should be practiced to prevent their development. However, there is no guarantee for cure. Dialysis is the only treatment for chronic kidney failure of kidney donors.

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