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  5. Frequently Asked Questions: Kidney Precision Medicine Project (KPMP)

Frequently Asked Questions: Kidney Precision Medicine Project (KPMP)

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Applying

  1. Do I need to submit a Letter of Intent?
  2. What is the minimum required percent effort?
  3. When are applications due?
  4. Can a single investigator submit multiple applications to the KPMP?
  5. Can a single institution submit multiple applications to the KPMP?
  6. When will the KPMP awards be made?

Objectives

  1. What are the long-term goals of the KPMP?
  2. What does the KPMP expect to accomplish in the first 5 years?
  3. How much money does the NIDDK plan to commit to the KPMP?
  4. How do the various KPMP activities fit together?
  5. What is a kidney tissue atlas?
  6. Whom should I contact if I have other questions about the KPMP?

Collaboration

  1. Will the KPMP investigators have to collaborate?
  2. Will the KPMP studies be undertaken exactly as proposed?
  3. How will data and samples move between the various KPMP activities?
  4. Will the broader research community have access to the KPMP data and samples?
  5. What data analysis will be done by the KPMP investigators?
  6. What data analysis will be done by the broader research community?
  7. How will AKI and CKD participants inform the KPMP?
  8. What is the KPMP Participant Engagement Working Group?
  9. What information will be returned to AKI and CKD participants?
  10. How often will the KPMP investigators travel to Bethesda?
  11. Who will serve on the KPMP Steering Committee?
  12. Who will provide external oversight of the KPMP?
  13. Will Industry be involved?
  14. What is the KPMP Opportunity Pool?

Applying

Do I need to submit a Letter of Intent?

Although a Letter of Intent is not required and does not impact review, it allows the NIDDK to plan the peer-review. If you intend to submit an application to any of the three KPMP FOAs, please email a Letter of Intent by November 6, 2016 to NIDDKletterofintent@mail.nih.gov. Please include:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of the FOA (Recruitment Sites = RFA-16-026; Tissue Interrogation Sites = RFA-16-027; Central Hub = RFA-16-028).

What is the minimum required percent effort?

PIs must declare a minimum effort of 2.4 person-months (20%) per year on all KPMP applications. Applications proposing Multiple PIs must have a minimum combined effort of 2.4 person months (20%) per year.

When are applications due?

All KPMP applications are due December 6, 2016.

Can a single investigator submit multiple applications to the KPMP?

Yes. As long as there is no scientific or budgetary overlap between the applications and the PI(s) meets the required minimum effort of 2.4 person-months (20%) effort per year.

Can a single institution submit multiple applications to the KPMP?

Yes and no.

Yes. Assuming no scientific or budgetary overlap, a single institution can submit multiple applications for Recruitment Sites and/or Tissue Interrogation Sites. In other words, a single institution can submit multiple applications for Recruitment Sites, Tissue Interrogation Sites, or both Recruitment Sites and Tissue Interrogation Sites.

No. A single institution cannot submit multiple applications for the Central Hub.

Together, this means that a single institution can submit multiple applications for Recruitment Sites and/or Tissue Interrogation Sites.  That same institution can also submit one application for the Central Hub.

When will the KPMP awards be made?

It is anticipated that all the initial KPMP awards will be made in July 2017.

Objectives

What are the long-term goals of the KPMP?

Recent advances in multi-scale interrogation of human tissue and single cells have set the stage for precision medicine to be applied to kidney disease. The objectives of the KPMP are to ethically obtain and evaluate human kidney biopsies from participants with AKI or CKD, create a kidney tissue atlas, define disease subgroups, and identify critical cells, pathways and targets for novel therapies. Specifically, the KPMP aims to develop or facilitate:

  • Public resource. Establish a publicly available data hub with clinical, imaging, cellular and molecular data. Anonymized data will be available to the research community upon validation.
  • Kidney tissue atlas. Create a set of maps used to classify and locate different cell types and interstitial components. The atlas will help define disease subgroups and identify cells, pathways and targets for novel therapies.
  • State/transition markers. Identify a set of cellular and molecular markers that classify cells as healthy, injured, activated, or undergoing recovery via adaptive or maladaptive repair.
  • Disease subgroups. Use all available data, including the kidney tissue atlas, to define participant subgroups and allow for clinical stratification into distinct endophenotypes.
  • Molecular pathways. Use data to identify and understand healthy and disease pathways that are activated in a particular cell type in a particular subgroup of participants.
  • Biomarkers. Discover a set of subgroup and pathway biomarkers. Ideally plasma or urine protein/antibody pairs, but could be urinary exosomes, miRNA, epigenetic marks, etc.

Target identification and biomarker validation are currently outside the scope of the KPMP.

What does the KPMP expect to accomplish in the first 5 years?

It is anticipated that the KPMP will be conducted in stages:

  • Stage 1: Optimize and validate tissue processing and interrogation methods. Establish common clinical protocols and cohort studies enrolling a small number of AKI or CKD participants. Assess quality of phenotype data and biopsy protocols at each site. Begin work on kidney tissue atlas. Optimize next generation assays. Stage 1 will roughly correspond to the UG3 “exploratory phase” of the Recruitment Sites and Tissues Interrogation Sites. It will also roughly correspond to years 1-2 of the Central Hub.
  • Stage 2: Small scale proof of concept studies to determine if clinical and analytic pipelines are robust. Implement next generation tissue interrogation assays. Enrich the kidney tissue atlas. Expand longitudinal cohort studies in initial AKI or CKD populations. Stage 2 will roughly correspond to the UH3 “implementation phase” of the Recruitment Sites and Tissues Interrogation Sites. It will also roughly correspond to years 3-5 of the Central Hub.
  • Stage 3: Expand to larger cohort studies. Stage 3 is expected to occur in the next 5-year funding cycle of the KPMP.

Download a Diagram of these stages (PDF 121 KB).

How much money does the NIDDK plan to commit to the KPMP?

The NIDDK intends to commit at least $6,750,000 per year for 5 years starting in FY 2017. We anticipate awarding 3-5 Recruitment Sites, 4-5 Tissue Interrogation Sites and 1 Central Hub,

The exact allocation of funds will be determined by the NIDDK based on scientific merit (as recommended by peer-review) and programmatic priority (in consultation with the NIDDK National Advisory Council).

How do the various KPMP activities fit together?

The KPMP will be made up of three distinct, but highly interactive activities:

  1. Recruitment Sites (RS): recruit people with AKI or CKD for longitudinal cohort studies that include a research kidney biopsy.
  2. Tissue Interrogation Sites (TIS): use and develop innovative technologies to analyze human kidney tissue.
  3. Central Hub (CH): aggregate, analyze and visualize all data and samples, and provide scientific, infrastructure and administrative support for the entire KPMP.

Download a Diagram of these stages (PDF 121 KB).

What is a kidney tissue atlas?

A set of 2- or 3-D maps used to classify and locate ('paint') different cell types, cell states (healthy, injured, dying, recovering, undergoing adaptive/maladaptive repair, etc.) and interstitial components (collagens, proteoglycans, signaling molecules, etc.). The maps will represent health and disease across a diverse population (accounting for sex, age, race, and ethnicity). The maps will include specific genes, proteins, RNAs, miRNAs, and/or epigenetic landmarks that are visualized by advanced imaging. The maps should facilitate identification of cell, structural, and regional heterogeneity throughout the kidney biopsy, and allow for interrogation of compartments that are currently difficult to visualize (e.g., interstitium, glomerulus). The atlas will ultimately be used to improve the diagnosis, staging, grading, prognosis, subgroup stratification, and drug effect prediction in AKI and CKD.

Whom should I contact if I have other questions about the KPMP?

Collaboration

Will the KPMP investigators have to collaborate?

Yes. All data, samples, protocols and technologies will be shared with all the KPMP investigators.  Moreover, all de-identified data and samples and all protocols and technologies will be shared with the broader scientific community as soon as the appropriate quality control measures are met.

Will the KPMP studies be undertaken exactly as proposed?

No. The KPMP investigators will collaboratively devise a set of studies that will be reviewed by the EEP and approved by the NIDDK.  Thus, all studies proposed in the applications will be a starting point for discussions regarding the research to be undertaken.  It is unlikely that any proposed research will be undertaken exactly as planned, or exclusively at an individual site.

How will data and samples move between the various KPMP activities?

All data and samples from the Recruitment Sites and Tissue Interrogation Sites must go to the Central Hub. The Central Hub will pay for all shipping and handling and coordinate quality control.

Will the broader research community have access to the KPMP data and samples?

Yes. All de-identified data and samples will be shared with the broader scientific community as soon as the appropriate quality control measures are met.

What data analysis will be done by the KPMP investigators?

All data and samples from the Recruitment Sites and Tissue Interrogation Sites will go to the Central Hub. In addition to an Administrative Core (AC), the Central Hub will have a Data and samples Coordinating Center (DCC) and a Data Visualization Center (DVC).

The Data and samples Coordinating Center (DCC) will perform standard clinical data assessments (e.g., participant data reports, recruitment tables, observational study reports), whereas the Data Visualization Center (DVC) will perform digital pathological assessments, create a kidney tissue atlas (incorporating data and images generated by the Recruitment Sites and Tissue Interrogation Sites) and foster advanced data analysis and visualization.

What data analysis will be done by the broader research community?

As much as possible.  The Central Hub will develop and manage a public interface to:

  • Build focus area-specific domains to facilitate interactions.
  • Develop and adapt innovative tools for navigating, analyzing, visualizing, and downloading data to maximize broad usability.
  • Incentivize public interrogation and discovery.

How will AKI and CKD participants inform the KPMP?

The KPMP will work closely with study participants to ensure that their viewpoints, priorities, and preferences inform all aspects of the KPMP. Specific roles will be determined by the Participant Engagement Working Group, to be established by the Administrative Core of the Central Hub.

What is the KPMP Participant Engagement Working Group?

The Administrative Core of the Central Hub will establish and support a Participant Engagement Working Group to educate AKI and CKD participants, physicians and other stakeholders about the need and ethical basis for performing research kidney biopsies. Specifically, it will:

  • Identify key participant-centered factors to be included in the development of common protocols for obtaining informed consent and performing research kidney biopsies.
  • Develop novel approaches for actively engaging relevant local stakeholders (e.g., participants, physicians, IRB representatives, ethicists, providers) in the development of research kidney biopsy protocols that ensure safety, minimize risk and adhere to the principles delineated in federal guidelines for research. Do not propose to use national groups such as the Participant and Family Partnership of the Kidney Health Initiative (KHI; a joint venture between the American Society of Nephrology and FDA), as they will be added once the KPMP is formed.
  • Disseminate engagement strategies, based on participant and provider input.
  • Develop a plan for continued engagement with participants as the research progresses, including a participant-centered information system that will offer clinical diagnoses for enrolled participants and their providers.
  • Develop a communication plan to disseminate proposed operating procedures and results to the larger kidney research and participant communities.

What information will be returned to AKI and CKD participants?

The KPMP will encourage the return of all study and diagnostic data back to study participants and the (re)incorporation into EHR systems as feasible and appropriate.

How often will the KPMP investigators travel to Bethesda?

It is anticipated that all key personnel will need to travel in-person to the Bethesda MD/Washington DC area at least two times per year throughout the project period, including the launch meeting, which is planned for either August or September of 2017. Please budget accordingly.

Who will serve on the KPMP Steering Committee?

The Steering Committee will be the primary governing body for the KPMP scientific activities. The voting membership of the Steering Committee will include one PI from each KPMP award, the NIDDK Project Scientist, and a representative from the KPMP Participant Engagement Working Group. The Chair of the Steering Committee will be assigned by the NIDDK and may be chosen from outside the KPMP. Face-to-face meetings of the Steering Committee will occur at least two times a year in the Bethesda MD/Washington DC area. Please budget for travel accordingly.

Who will provide external oversight of the KPMP?

All KPMP activities will be overseen by an Observational Safety Monitoring Board (OSMB) that will focus on participant safety, study burden and scientific validity of the clinical data and an External Evaluation Panel (EEP) that will focus on the overall scientific progress and direction of the KPMP. The NIDDK will constitute the OSMB and EEP. Do not propose members in your application. Applications that propose members for the OSMB or EEP may be considered not responsive.

Will Industry be involved?

Industry (Pharmaceutical and Biotechnology) may participate in the KPMP to expand the scope, size, and/or complexity of the project. In your application, you should state a willingness to work with Industry partners/collaborators in a pre-competitive research arena.

What is the KPMP Opportunity Pool?

It is a pool of KPMP funds – administered by the Central Hub – to form new partnerships with investigators from both inside and outside of the KPMP.

Specifically, the KPMP Opportunity Pool Program will:

  • Continually monitor the scientific, infrastructure and resource needs of the KPMP.
  • Develop requests for applications, manage acceptance and organize external peer-review.
  • Establish an administrative structure to select projects for funding, disburse and track awards.
  • Establish procedures, formats and timelines, for monitoring and reporting, progress and outcomes (e.g., publications, subsequent awards).

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