Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation
Public ClinicalTrials.gov record NCT04226859. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Multicenter International Observational Study to Identify eGFR Trajectories and Their Determinants, and to Build a Multidimensional Prediction System to Predict the Probabilities of Belonging to eGFR Trajectories
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD). However, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described. An unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease. Therefore, this study aims: 1. To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models; 2. To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions; 3. To investigate the associations of the eGFR trajectories with the progression to ESRD and death. Based on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.
Study identification
- NCT ID
- NCT04226859
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 14,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 1999
- Primary completion
- May 31, 2020
- Completion
- May 31, 2020
- Last update posted
- Jan 17, 2020
2000 – 2020
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center | Los Angeles | California | 90048 | Enrolling by invitation |
| Department of Surgery, Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | Enrolling by invitation |
| William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic | Rochester | Minnesota | 55905 | Enrolling by invitation |
| Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program | New York | New York | 10467 | Enrolling by invitation |
| Virginia Commonwealth University School of Medicine | Richmond | Virginia | 980663 | Enrolling by invitation |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04226859, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 17, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04226859 live on ClinicalTrials.gov.