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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases; Pregnancy Related

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with pre-existing chronic kidney disease, defined as eGFR < 90mls/min/1.73m2 within 24 months of conception.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Dataset 1: National Registry of Rare Kidney Diseases; 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; Maternal and laboratory data from East and West Kent in the UK.
Dataset 3: Stockholm Creatinine Measurement; An observational dataset with laboratory data from individuals in Stockholm (Sweden)
Dataset 4: Ontario Renal Network Pregnancy Cohort; 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; A combined cohort derived from three obstetric studies within the UK.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome a 25% or greater decline in eGFR between six weeks and 12 months postpartum or initiation of dialysis	A >=25% reduction in eGFR between six weeks and 12 months postpartum or initiation of dialysis.	Six weeks to 12 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome: a preterm birth less than 34 weeks or small for gestational age less than 3rd percentile.	A composite outcome of preterm birth defined as less than 34 weeks gestation and/or SGA < 3rd percentile.	To be recorded within 24 hours of date of delivery (Index event is the day of delivery). This outcome is measured on date of delivery.

Collaborators and Investigators

• Sponsor: King's College London

Publications and helpful links

General Publications

• Wiles K, Webster P, Seed PT, Bennett-Richards K, Bramham K, Brunskill N, Carr S, Hall M, Khan R, Nelson-Piercy C, Webster LM, Chappell LC, Lightstone L. The impact of chronic kidney disease Stages 3-5 on pregnancy outcomes. Nephrol Dial Transplant. 2021 Nov 9;36(11):2008-2017. doi: 10.1093/ndt/gfaa247.
• Tong A, Jesudason S, Craig JC, Winkelmayer WC. Perspectives on pregnancy in women with chronic kidney disease: systematic review of qualitative studies. Nephrol Dial Transplant. 2015 Apr;30(4):652-61. doi: 10.1093/ndt/gfu378. Epub 2014 Dec 18.
• Piccoli GB, Zakharova E, Attini R, Ibarra Hernandez M, Orozco Guillien A, Alrukhaimi M, Liu ZH, Ashuntantang G, Covella B, Cabiddu G, Li PKT, Garcia-Garcia G, Levin A. Pregnancy in Chronic Kidney Disease: Need for Higher Awareness. A Pragmatic Review Focused on What Could Be Improved in the Different CKD Stages and Phases. J Clin Med. 2018 Nov 5;7(11):415. doi: 10.3390/jcm7110415.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: PREDICT_Protocol_V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No