SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK

(SOW)

GENERAL INFORMATION

Title of Project:

Fibrosis markers in kidney disease associated with dementia.

Statement of Need and Purpose:

The contractor shall develop the animal models of chronic kidney disease (CKD). These models include partial nephrectomy (PNX) model and non-surgical dietary model, accompanied by fibrosis, thrombosis and/or by changes in paraoxonases (PONs; the enzymes, responsible for the utilization of the steroids).

Background Information and Objective:

The prevalence of chronic kidney disease (CKD) and cognitive impairment (CI) increases with age. CKD is a significant risk factor in the development of CI. CKD is greater in females vs.

males due to a higher risk of renal infections and a decline of protective hormones with age.

Cardiovascular diseases (CVD) and increased central arterial stiffness (CAS) accompany development of CKD and CI. The markers of CVD and CKD, specifically Angiotensin II, aldosterone, MBG, brain natriuretic peptide (BNP), transforming growth factor beta 1 (TGF-beta1), amyloid beta, paraoxonase (PONs), and the pro-thrombosis factors, can be measured in urine, plasma and tissues. The animal models of CKD are accompanied by increased risk of thrombosis, bleeding and susceptibility to venous thromboembolism, which contribute to the development of CI. Females may have a higher risk of CVD-CKD-CI development. CKD, CAS and CVD may potentiate the development of CI.

The Study Objectives are to determine whether CKD potentiates development of CI due to CAS and whether the CAS markers levels increase in CKD.

Period of Performance:

Anticipated period of performance: six (6) months after date of award.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The Contractor shall assess the leucocyte adhesion to the carotid arterial vessel wall, platelet adhesion and activation, histological examination of vessel stiffness, and measurement of fibrosis markers from tissue and plasma samples.

The Contractor shall consult Dr. Fedorova on the CKD model. The National Institute on Aging (NIA), Laboratory of Cardiovascular Science (LCS) will provide the Contractor the rat samples (plasma, urine, tissues) for the measurement of the proteins and markers, responsible for CKD (Angiotensin II, aldosterone, MBG, brain natriuretic peptide (BNP), transforming growth factor beta 1 (TGF-beta1), amyloid beta, paraoxonase (PONs), and the pro-thrombosis factors). The Contractor shall measure the following:

• Assays (Angiotensin II, Aldosterone, BNP, TGF-beta1, amyloid beta, PONs – 6 markers)

• qPCR for fibrosis markers

• Development of the CKD model and checking the CKD profile

CONTRACTOR RESPONSIBILITIES

The Contractor shall provide written description of the results and of the methods, the data analysis, and experimental suggestions.

The Contractor shall report all interpretations and suggestions to the LCS/Cardiac Function Section/ Hypertension Unit staff meetings in the last 30 days of the period of performance.

GOVERNMENT RESPONSIBILITIES

Reviewing and approving reports generated under the contract will be performed by Olga Fedorova (BRC, 8B117, LCS).

The government will provide data sets for the contractor’s review.

The contractor will NOT require access to the NIA Biomedical Research Center 251 Bayview Boulevard, Baltimore, MD 21224-6825

DELIVERY OR DELIVERABLES

1. CKD animal model along with profile

2. Leukocyte and platelet adhesion profile, Histological stiffness profile 3.Biochemical data set : Angiotensin II, Aldesterone, BNP, TGF-beta1, amyloid beta and PON

All deliverables shall be submitted at the end of the 6 month period of performance.

REPORTING REQUIREMENTS

The contractor shall submit a project report at the completion of the period of performance electronically to Dr. Olga Fedorova, LCS.

The contractor shall report to LCS/Cardiac Function Section/ Hypertension Unit staff meetings all interpretations and suggestions by 10/30/2021.

OTHER CONSIDERATIONS

Travel:

Travel is not required.

Key Personnel:

Contractor should have extensive experience in the field of Hypertension with specific focus on Chronic Kidney disease. Personnel must have clinical experience with CKD and extensive biochemical analysis proficiencies.

Information System Security Plan:

N/A

Data Rights:

All data rights regarding the use, production, and disclosure of that data belong to the NIH and the Contractor. The Contractor has the publication rights to data generated under this contract with a co-authorship with NIH.

Section 508—Electronic and Information Technology Standards:

Information technology is not to be acquired by the Contractor.

Publications and Publicity:

N/A

Confidentiality of Information:

N/A