Condition category
Urological and Genital Diseases
Date applied
22/07/2020
Date assigned
25/08/2020
Last edited
25/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Creatinine is a chemical waste product that's produced as a result of muscle movement and to a smaller extent by eating meat. Healthy kidneys filter creatinine and other waste products from your blood. The filtered waste products leave your body in your urine. In patients with kidney disease, as the disease progresses, the level of creatinine in the blood rises.

Glomerular filtration rate is another way to determine the extent of kidney disease and test the level of kidney function.

Based on a previous literature review, it was thought that supplementation with certain amino acids may have a role in improving renal (kidney) function as they have been shown to decrease blood-serum creatinine concentration and increase the glomerular filtration rate.

The trial aims to find whether oral supplementation with a specific amino acid/peptide complex will stabilize or improve the estimated glomerular filtration rate in humans with declining kidney function and if there is rationale for conducting a future randomized controlled trial with larger sample size.

Who can participate?
Non-diabetic white males aged 63 to 80 years under concurrent medical care in the United States, with chronic kidney disease (CKD) or an increased fall in kidney function over the previous 24 months.

What does the study involve?
Participants will take the supplement AB070597 (via mouth) daily for 10 months. They will give blood samples monthly during this period.

What are the possible benefits and risks of participating?
AB070597 supplementation may stabilize or improve renal function.

There are no known risks from taking dietary supplement AB070597.
Risks from blood collection include potential pain from the needle stick, and/or bruising.

Where is the study run from?
Quest Diagnostics (USA)

When is the study starting and how long is it expected to run for?
From April 2016 to May 2017

Who is funding the study?
John T Fulton Trust (USA)

Who is the main contact?
Dr James Archer
photoresearch@sbcglobal.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Archer

ORCID ID

http://orcid.org/0000-0003-2245-8509

Contact details

4848 Olive Hill Road (28 Rolling View)
Fallbrook
92028
United States of America
+1 7607232316
photoresearch@sbcglobal.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

AB070597-5H

Study information

Scientific title

Exploratory-data and statistical analyses of AB070597, an amino acid and peptide complex, on blood-serum creatinine concentration and estimated glomerular filtration rate: a non-randomized pilot trial of five humans with declining renal-function

Acronym

Study hypothesis

Oral supplementation with a specific amino acid/peptide complex will stabilize or improve the estimated glomerular filtration rate in humans with chronologically declining renal function

Ethics approval

Approved 10/18/2016, Pearl IRB (29 E McCarty Street, Suite 100, Indianapolis, IN 46225 USA; +1 317-602-6104; gparker@pearlpathways.com), ref: 16-BIOS-101

Study design

Single-center open-ended longitudinal non-randomized, non-controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Dr. James Archer (photoresearch@sbcglobal.net) to request a patient information sheet

Condition

Declining renal function in chronic kidney disease

Intervention

The intervention is oral administration of a daily dose of a specific amino acid/peptide complex. All participants are asked to follow the dosing schedule of six 1000 mg capsules, taken twice daily. Each capsule contains: 83 mg L-arginine, 167 mg glycine, 167 mg L-glutamine, 83 mg L-histidine, 167 mg L-aspartic acid, 167 mg L-glutamic acid, 167 mg L-carnosine.

Treatment continued for 12 consecutive months, with blood-serum creatinine concentration measured at 1-month intervals.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

1. Estimated glomerular filtration rate (eGFR) calculated from participant age and blood-serum creatinine concentration at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
2. Individual eGFR median-rate-of-change per unit time compared to eGFR medium-rate-of-change per unit time of 2870 chronic kidney disease participants in a study by Tsai CW, et al. (2017) using non-parametric one-sample Wilcoxon signed-rank test

Secondary outcome measures

1. Estimated glomerular filtration rate measured by blood-serum creatinine and age at baseline, 12, 34, and 36 weeks

Overall trial start date

01/11/2016

Overall trial end date

30/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 63 to 80 years
2. White
3. Male
4. Under concurrent medical care in the United States
5. Chronic kidney disease (CKD) or an estimated glomerular filtration rate (eGFR) decline rate of ≥4 ml/min/1.73 m² over the previous 24 months
6. History of increasing blood-serum creatinine from CKD or as a consequence of aging

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

5

Total final enrolment

5

Participant exclusion criteria

1. Concurrent or suspected comorbidities unrelated to CKD
2. Diabetic

Recruitment start date

30/11/2016

Recruitment end date

30/11/2017

Locations

Countries of recruitment

United States of America

Trial participating centre

Quest Diagnostics
555 E. Tachevah Dr. Ste. 102 W Palm Springs
California
92262
United States of America

Trial participating centre

Davita Pomona Dialysis
2111 N. Garey Ave. Pomona
California
91767
United States of America

Trial participating centre

Quest Diagnostics
23441 Madison Street, Suite 300 Torrance
California
90505
United States of America

Trial participating centre

Quest Diagnostics
11525 Brookshire Avenue, Suite 401 Downey
California
90241
United States of America

Trial participating centre

Quest Diagnostics
8401 Fallbrook Ave. West Hills
California
91304
United States of America

Sponsor information

Organisation

Whitsell Innovations

Sponsor details

18 Kendall Drive
Chapel Hill
North Carolina
27517
United States of America
+1 (919) 321-9017
info@whitsellinnovations.com

Sponsor type

Industry

Website

https://www.whitsellinnovations.com/

Funders

Funder type

Charity

Funder name

John T Fulton Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analyzed during the current study are/will be available to reasonable requests from the Applied Research Laboratory. Contact Dr. James Archer at photoresearch@sbcglobal.net.

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/08/2020: Trial’s existence confirmed by Pearl IRB.