EN 
ES 
NephCure – PARASOL Grant Program
Objectives
NephCure in cooperation with the International Society of Glomerular Diseases, the Kidney Health Initiative, and the National Kidney Foundation announces a research grant program to support the PARASOL project. PARASOL is a collaborative international effort that aims to define the quantitative relationships between short-term changes in biomarkers (proteinuria and GFR) and long-term outcomes in order to support the use of alternative proteinuria-based endpoints as a basis for accelerated and traditional approval.
The PARASOL group will achieve this in 2024 by conducting a large-scale analysis of existing data from patients of all ages with FSGS who have participated in observational cohort studies, completed clinical trials, regional or national registries, or real-world data sets.
Meritorious Characteristics
Proposals will be evaluated for their compliance with the guiding principles described above. The following project characteristics will be considered meritorious if:
- The proposed project is willing and able contribute necessary and valuable data or statistical expertise to the PARASOL project to support achievement of PARASOL aims.
- The proposed project leads are able to meet the timelines established for PARASOL project success.
Eligibility
There are two programs supported under this announcement.
1) The clinician investigator program is open to all investigators or clinicians who oversee an existing cohort study, registry, or real-world data inclusive of substantial FSGS patient data meeting the dataset eligibility criteria defined by the PARASOL Data Analysis Team.
2) The statistician program is open to individuals with key expertise in statistical planning and execution that will support the design and conduct of the statistical analysis necessary for this project.
Dataset Eligibility
- Ability to define cohort based on eligibility criteria below
- Proteinuria and serum creatinine at biopsy/diagnosis and longitudinally.
- Ascertainment of kidney failure and death per definitions above.
- At least 100 participants meeting inclusion criteria in Table 2 AND:
- ≥24 months of follow-up
- ≥3 UPCR measurements 6-24 months post-index UPCR (any)
- ≥3 eGFR measurements 6-24 months post-index UPCR in prior bullet
Funding
NephCure will award funds in accordance with anticipated costs per project to support high quality dataset contributions and statistical leadership to PARASOL. To protect the integrity of the PARASOL study and ensure regulatory compliance, applying registries and individuals must be reviewed and approved by the PARASOL Organizing Committee before submission of a proposal for funding from NephCure.
- Projects will be funded directly by NephCure to the recipient institutions.
- Budget and justification will be reviewed by the PARASOL Finance Committee in consultation with the PARASOL Organizing Committee and decision will be made regarding support needed to ensure high quality registry data is able to be contributed.
- Funds will be provided to cover project direct costs only. No indirect costs. NephCure has a long-standing policy to support direct costs only.
- The number of projects funded during will be dictated by the size of project budgets requested and awarded. NephCure makes this determination at the time of review.
| Dataset-Required Criterion | Definition |
| Biopsy-proven or monogenic FSGS | Documented description of adjudication of FSGS diagnosis |
| Index UPCR≥1 g/g (or equivalent g/day) | At least one UPCR≥1 g/g at or after biopsy/diagnosis (or up to 3 months prior to biopsy/diagnosis) |
| Index eGFR≥30 ml/min/1.73m2 | eGFR measurement must be within ±3 months from index UPCR |
| UPCR measurement 6-24 months after index date | ≥1 UPCR measurement 6-24 months after index UPCR |
| No evidence of kidney failure (see above definition) within 6 months | No kidney failure events prior to the first observed UPCR>6 months post-index date |
Application/Review Process
The process of submitting applications to NephCure for this grant program occurs in 2 steps. No application can be submitted to NephCure before approval of/invitation by the PARASOL Organizing Committee, which assesses proposals for feasibility.
- PARASOL Organizing Committee Approval: The investigator meets with the PARASOL intake team to discuss PARASOL objectives and alignment and feasibility of including the proposed registry/dataset. An assessment of contributing registry/dataset value is provided to the PARASOL Organizing Committee. Approval and invitation to submit is necessary prior to submission for funding.
- Grant Submission to NephCure: Once the PARASOL Organizing Committee approves the proposed registry/dataset, the investigator will be invited to submit a grant proposal to NephCure utilizing the application template provided. NephCure, in conjunction with the PARASOL grant review committee, is responsible for funding decisions.
Deadline: There is no formal deadline for the application and applications are reviewed on a rolling basis. Applicants may discuss the application process with Dr. Laura Mariani lmariani@med.umich.edu prior to making an application.
Application Format
Please complete and submit using the PARASOL grant application template.
Terms of Support
- Funds (direct costs only) are provided to investigator’s institution for use by the applicant; it is the applicant institution’s obligation to ensure proper use of funds and timely submission of progress reports. Funds will be provided to cover project direct costs only. No indirect costs. NephCure has a long-standing policy to support direct costs only.
- Disbursal of grant funds will be made in 2 payments. 50% of payment will be made upon notice of award and remaining 50% will be paid following either receipt of registry data in format established by PARASOL Data Analysis Committee or confirmation by the PARASOL Data Analysis Committee of active participation and substantial committee to statistical planning.
- Principal investigators must comply with human institutional review board requirements and demonstrate current approval of these committees.
- It is expected that data provided to the coordinating center will be shared in a de-identified manner with contributing registries within PARASOL.
- It is expected that publications will be submitted in compliance with the publications policies of PARASOL.
- NephCure support will be acknowledged by grantees in publications, presentations, abstracts, and other relevant press releases and on associated websites.
- NephCure does not discriminate on the basis of race, gender, religious, or ethnic group; applicants should assure compliance with this policy in designing and executing their studies.
