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

Pregnancy Related Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05793346
• Other study ID #: PREDICT_Protocol_V1
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Pregnancy Related
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.