← Back to Search

Exercise & Supplements for Chronic Kidney Disease (NeurovEx Trial)

Phase 2
Recruiting
Led By Joe Nocera, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable renal function, with no greater than a 30% reduction in eGFR over the prior 3 months
Stage III or IV Chronic Kidney Disease, defined as reduction in estimated glomerular filtration rate (eGFR) to 15-59 cc/minute as calculated by the modified Modification of Diet in Renal Disease (MDRD) Study equation or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Awards & highlights

NeurovEx Trial Summary

This trialwill study if exercise, Kuvan, and/or histidine/beta-alanine help people with CKD improve exercise capacity & lower blood pressure during exercise.

Who is the study for?
This trial is for adults with moderate to severe chronic kidney disease (stages III or IV), which means their kidneys don't filter blood well. They should have stable kidney function without major changes in the last 3 months and not be regular exercisers, working out less than 40 minutes per week.Check my eligibility
What is being tested?
The study looks at why patients with CKD struggle with exercise and high blood pressure during it. It tests if cycling, a drug called Kuvan (6R-BH4), or supplements like histidine and beta-alanine can help improve these issues. Some participants will receive placebos instead of actual drugs.See study design
What are the potential side effects?
Possible side effects may include reactions to supplements or medication such as digestive discomfort, skin reactions, headaches, or dizziness. Exercise might cause muscle soreness or fatigue.

NeurovEx Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney function has been stable, with less than a 30% drop in efficiency.
Select...
My kidney function is moderately to severely reduced.

NeurovEx Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in exaggerated pressor responses during exercise
Change in functional sympatholysis
Change in vascular alpha 1 adrenergic responsiveness
Secondary outcome measures
Change in endothelial function
Change in vascular stiffness
Renal artery resistance during exercise

NeurovEx Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Exercise training + 6R-BH4Experimental Treatment3 Interventions
Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take the study drug 6R-BH4.
Group II: Exercise training + histidine and beta-alanine placeboActive Control2 Interventions
Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo to match the histidine and beta-alanine supplementation.
Group III: Exercise training + histidine and beta-alanineActive Control2 Interventions
Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take histidine and beta-alanine supplementation.
Group IV: Exercise training + 6R-BH4 placeboActive Control3 Interventions
Participants randomized to this arm will exercise on a stationary bicycle for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo to match the study drug 6R-BH4.
Group V: Stretching + 6R-BH4Active Control3 Interventions
Participants randomized to this arm will do muscle stretching and toning for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take the study drug 6R-BH4.
Group VI: Stretching + placeboPlacebo Group3 Interventions
Participants randomized to this arm will do muscle stretching and toning for 20-45 minutes, 3 times per week, for 6-12 weeks. This arm will also take a placebo instead of the active study drug.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folic acid
2008
Completed Phase 4
~8330

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,546 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,838 Previous Clinical Trials
47,851,504 Total Patients Enrolled
Joe Nocera, PhDPrincipal InvestigatorEmory University

Media Library

6R-BH4 Clinical Trial Eligibility Overview. Trial Name: NCT02947750 — Phase 2
Chronic Kidney Disease Research Study Groups: Exercise training + histidine and beta-alanine placebo, Exercise training + histidine and beta-alanine, Stretching + placebo, Exercise training + 6R-BH4, Exercise training + 6R-BH4 placebo, Stretching + 6R-BH4
Chronic Kidney Disease Clinical Trial 2023: 6R-BH4 Highlights & Side Effects. Trial Name: NCT02947750 — Phase 2
6R-BH4 2023 Treatment Timeline for Medical Study. Trial Name: NCT02947750 — Phase 2

Frequently Asked Questions

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

Are there any precedential experiments that have combined Exercise training with other treatments?

"At present, there are 5 on-going trials for Exercise training that have not yet reached the third phase of testing. Although most are located in Chengdu, Sichuan Province, a total of 18 centers across the globe offer this type of research."

Answered by AI

What potential risks accompany an exercise regimen?

"Although Phase 2 trials do not necessarily demonstrate efficacy, there is sufficient evidence to suggest exercise training has a safety ranking of 2."

Answered by AI

How many participants are being monitored during this clinical research?

"Affirmative, the information hosted on clinicaltrials.gov confirms that this experiment is actively enrolling participants. The trial was first documented on October 1st 2016 and most recently updated on October 13th 2022; 150 people are required from 3 distinct medical sites."

Answered by AI

Is this a pioneering venture in the medical field?

"At present, there are 5 active studies on Exercise training in 4 cities and 6 nations. The initial trail commenced back in 2013 which was organised by BioMarin Pharmaceuticals and included 34 participants who completed Phase 4 drug tests. In the 8 years since then, a total of 158 clinical trials have been finished."

Answered by AI

Are participants presently being enrolled in this experiment?

"According to the info from clinicaltrials.gov, this research project is actively seeking participants. It was initially posted on October 1st 2016 and most recently updated on October 13th 2022."

Answered by AI

Is this experiment specifically targeting elderly individuals?

"To be eligible for this study, individuals must fall between the age of 18 and 75 years old. Separately, there are 48 clinical trials targeting minors while 566 studies focus on participants aged 65 and above."

Answered by AI

To whom is enrollment in this trial open?

"This clinical trial is searching for 150 individuals from ages 18 to 75 suffering from Chronic Kidney Disease. To be eligible, they must meet the following criteria: Stage III or IV CKD, eGFR between 15-59 cc/minute as determined by MDRD Study equation or CKD-EPI equation, lack of regular exercise (less than 20 minutes twice per week), and a willingness to comply with study protocol regulations."

Answered by AI

Who else is applying?

What site did they apply to?
Emory University Hospital Midtown
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Neurovascular Transduction During Exercise in Chronic Kidney Disease
Jeanie Park 2016. "Neurovascular Transduction During Exercise in Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02947750.
All > Chronic Kidney Disease
~8 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top