Exploratory-Data and Statistical Analyses of AB070597, an Amino Acid/Peptide Complex, on Blood-Serum Creatinine Concentration and Estimated Glomerular Filtration Rate: A Non-Randomized Pilot Trial of Five Humans with Declining Renal Function

Abstract

ABSTRACT
 Background:
 Chronic kidney disease (CKD) develops from persistent, irremediable loss of renal function (RF). Animal studies show that dietary supplement, AB070597, an amino acid/ peptide complex, can stabilize, and in some instances, reverse CKD. Previous human CKD studies demonstrate that dietary treatment with specific keto acids and amino acids can lower blood-serum creatinine concentration (SCr) and increase glomerular filtration rate (GFR). This pilot trial was performed to determine whether a future randomized controlled human clinical trial of AB070597’s effect on CKD was justified.
 Methods: 
 The trial was structured as a consecutive case series to evaluate whether oral treatment with AB070597 could slow CKD progression, as gaged by SCr, and estimated glomerular filtration rate (eGFR). Eligibility requirements: Non-diabetic white males under current medical care in the United States, diagnosed with CKD, or with histories of increasing SCr and declining eGFR, resulting from CKD or natural consequence of aging. Exclusion criteria: Concurrent or suspected comorbidities unrelated to CKD. Participants ingested 6-g bi-daily doses of AB070597 for periods up to 24 months. SCr was measured and eGFR calculated at approximate tri-monthly intervals. 
 Results:
 Results were presented as individual-participant and group SCr and eGFR vectors, and initial-data-analysis diagrams.
 Treatment reversed SCr slopes from positive to negative, and eGFR slopes from negative to positive. When individual participant’s median monthly eGFR rate-of-change (positive) was compared with the median monthly eGFR rate-of-change (negative) in a sample of 2870 humans with CKD, differences were significant in favor of the AB070597 treatment group in 4 of 5 participants: (P = 0.0625, 95% CI: 0.368-8.368), (P = 0.0313, 95% CI: 0.368-1.038), (P = 0.0039, 95% CI: 0.368-0.698), (P = 0.0010, 95% CI: 0.118-2.868),
 (P <0.0001, 95% CI: 0.368-10.370).
 Conclusion:
 Oral AB070597 treatment produced an apparently favorable change in CKD trajectory in 4 humans and in 1 with naturally age-related declining RF. The magnitude and direction of change hint that treatment may have had a beneficial effect on CKD progression and age-related RF. In and of themselves, this pilot trial’s results seem to favor CKD treatment with AB070597, but because there was no randomization, no control group, and a small sample size , it is not possible to extend results beyond its bounds. They do, however, support the rationale for a future randomized controlled trial