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

NCT05793346 | Unknown

• 1 other identifier: PREDICT_Protocol_V1
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Kidney Diseases; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcome: a preterm birth less than 34 weeks or small for gestational age less than 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.

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King's College London: lead

Related Publications (3)

• 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.

  PMID: 33313680 BACKGROUND

• 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.

  PMID: 25523452 BACKGROUND

• 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.

  PMID: 30400594 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 31, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share