Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05229263 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Multiparametric MRI in Healthy Volunteers and CKD Patients

Study acronym: RESPECT
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 2024 to Mar 13, 2025
    • Study completion date: Dec 2024 to Dec 2025
    • Site details revised at 4 of 4 sites
    v9
  2. Notable Primary completion date: Nov 2023 to Dec 2024
    • Study completion date: Dec 2023 to Dec 2024
    v8
  3. Minor Collaborators revised (3)v7
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2022 to Nov 25, 2022
    • Study sites revised (4)
    v6
  5. Notable Start date: Sep 2022 to Dec 2022v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Jul 2022 to Sep 2022v4
  2. Notable Start date: Mar 2022 to Jul 2022v3
  3. Minor Secondary endpoints: details revised at 1 of 38 entriesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population. The majority of the people with CKD aren't aware and there are not available tools for early CKD detection and for an accurate prediction on these patients. Many CKD patients exhibit progressive renal dysfunction, demonstrating a failure of current, non-specific therapeutic strategies. Better methods are urgently needed for i) early diagnosis of CKD, and prediction of its progression for improved stratification of patients and better targeting of current treatments; and ii) to directly assess structural and functional responses of the kidney to new therapies and identify those patients who respond. Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising technique for improved understanding and characterisation of renal pathophysiology. Compared to histopathology, MRI is non-invasive and avoids sampling bias by characterising the entire kidney with high spatial resolution. In spite of a number of single centre studies showing renal MRI feasibility and potential to address a number of key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Standardization of acquisition and processing protocols across centres is therefore needed, and this will also lead to the possibility to provide preliminary data of the multiparametric renal MRI clinical validity and utility. The purpose of this study is to standardize, assess the feasibility and provide preliminary evidence of clinical validity and utility of the multiparametric renal MRI. To reach this goal two groups of subjects are involved: * Group 1 (healthy volunteers). In this group the repeatibility and reproducibility of multiparametric renal MRI will be assessed. * Group 2 (CKD patients). In this group the feasibility, the acceptability, the reproducibility and the preliminary clinical validity of multiparametric renal MRI will be assessed.
Trial Details
NCT Number NCT05229263
Lead Sponsor Mario Negri Institute for Pharmacological Research
Collaborators: Clinica Universidad de Navarra, Universidad de Navarra, Aarhus University Hospital, Heidelberg University
Conditions
(from sponsor)
Chronic Kidney Diseases, Healthy
Related terms Renal Insufficiency, Chronic
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov