Pregnancy-associated Progression of Chronic Kidney Disease: A Study Protocol for the Development and Validation of a Clinical Predictive Tool (PREDICT)

King's College London

Status: Not yet enrolling

Conditions: Chronic Kidney Diseases; Pregnancy Related

Study type: Observational

Funder types: Other

Identifiers

NCT05793346

PREDICT_Protocol_V1

Details and patient eligibility

About

To develop and validate a tool that estimates the degree of pregnancy-associated progression of renal disease in women with CKD and pregnancy outcomes in an international multicentre cohort study.

Full description

The aim of this study is to develop and validate a tool that estimates the degree of pregnancy-associated progression of renal disease in women with CKD and pregnancy outcomes in an international multicentre cohort study. Two prediction models will be developed to estimate the likelihood of both outcomes. The models will be developed and internally validated in one cohort in the United Kingdom and then externally validated using four international datasets.

Enrollment: 5,000 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with an estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) without ethnicity adjustment, less than 90mls/min/1.73m2 within 24 months pre-conception will be included

Exclusion criteria

• Women established on dialysis at time of conception
• Multi-fetal pregnancies
• Known inpatient eGFR measurement
• No preconception eGFR within 24 months will be excluded.

Trial design

5,000 participants in 5 patient groups

Dataset 1: National Registry of Rare Kidney Diseases

Description:

This dataset is the: National Registry of Rare Kidney Diseases from the UK Renal Registry, this is a UK-wide, linked dataset. This cohort includes any woman who has previously had a previous diagnosis of kidney disease in the UK with maternity records and who has consented to participate.

Dataset 2: Kent Integrated Data

Description:

Maternal and laboratory data from East and West Kent in the UK.

Dataset 3: Stockholm Creatinine Measurement

Description:

An observational dataset with laboratory data from individuals in Stockholm (Sweden)

Dataset 4: Ontario Renal Network Pregnancy Cohort

Description:

A population-based cohort of women in Ontario who had an obstetric delivery with outpatient laboratory data.

Dataset 5: Combined cohort of three obstetric studies within the UK

Description:

A combined cohort derived from three obstetric studies within the UK.