NCT06416761

Brief Summary

This study evaluates the role of genetic in the development and progression of different nephropaties with particular attention to:

  • AKI
  • CKD
  • Hypertension
  • ADPKD
  • CKD-MBD
  • Patients with decompensated heart failure undergoing either medical or surgery therapy
  • Patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation
  • glomerular diseases

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
183mo left

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
May 2006May 2041

Study Start

First participant enrolled

May 19, 2006

Completed
18 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2040

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2041

Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

34 years

First QC Date

May 11, 2024

Last Update Submit

May 11, 2024

Conditions

Keywords

genetic in hypertensive kidney diseasesalt intake in BP control and CKD progressiongenetic in CKDendogenous Ouabain as marker of AKIprotein intake restriction in CKD progressionhypertension in allogenic bone marrow transplantation

Outcome Measures

Primary Outcomes (1)

  • difference in glomerular filtration rate according to genetic profile

    eGFR value

    from days to 35 years

Study Arms (1)

Patients with acute or chronic nephropathy

1. Patients with chronic nephropathies 2. Patients with acute nephropathy 3. Patients with nephrectomy 4. Candidate Patients to major surgery 5. Patients with decompensated heart failure undergoing either medical or surgical therapy 6. Acute critically ill patients (e.g sepsis, post-operative) 7. Patients with hypertension 8. Patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation. 9. Long-term surviving patients who received bone marrow transplantation.

Genetic: genetic polymorphisms

Interventions

Patients with acute or chronic nephropathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will evaluate different groups of adult patients: 1. Patients with chronic nephropathy 2. Patients with acute nephropathy 3. Patients with nephrectomy 4. Candidate Patients to major surgery 5. Patients with decompensated heart failure undergoing either medical or surgical therapy 6. Acute critically ill patients (e.g sepsis, post-operative) 7. Patients with hypertension 8. Patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation. 9. Long-term surviving patients who received bone marrow transplantation.

You may qualify if:

  • presence of specific renal disease

You may not qualify if:

  • to be evaluated in the different sub-protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood , urine and sample of renal tissue

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone DisorderRenal Insufficiency, ChronicPolycystic Kidney, Autosomal DominantHypertensionHematologic Neoplasms

Interventions

Polymorphism, Genetic

Condition Hierarchy (Ancestors)

RicketsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersVitamin D DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersHyperparathyroidism, SecondaryHyperparathyroidismParathyroid DiseasesEndocrine System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyPolycystic Kidney DiseasesKidney Diseases, CysticAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, InbornVascular DiseasesCardiovascular DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Genetic VariationGenetic Phenomena

Central Study Contacts

Chiara Livia Lanzani, prof

CONTACT

Laura Zagato, biologist

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant

Study Record Dates

First Submitted

May 11, 2024

First Posted

May 16, 2024

Study Start

May 19, 2006

Primary Completion (Estimated)

May 19, 2040

Study Completion (Estimated)

May 19, 2041

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations