AKINCT06416761
Genetics in the Progression of Nephropathies
An observational study of AKI and CKD, run by Ospedale San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- genetic polymorphisms
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 19 May 2006to 19 May 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- . presence of specific renal disease
Who cannot join
- to be evaluated in the different sub-protocols
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Chiara Lanzani, MD, +390226433891, lanzani.chiara@hsr.it
About this study
Official title: The Genetic Contribution to Progression of Kidney Disease
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
Read the detailed description
Background: In the past ten years there's been a progressive increase in the prevalence of CKD and consequently in the number of dialysed patients (~4% per year) in Italy. This is probably due to the increasingly ageing population and incidence of CV disease (cf. Lombardy Register). To date, diabetes and CV disease are the most common cause of end-stage renal disease (ESRD) requiring RRT. Nonetheless, intrinsic renal diseases still remain an important cause of CKD. In the past few years, various environmental factors have been identified that affect the clinical progression of kidney disease: blood pressure control, lipid and glycemic profile (expecially in the setting of diabetic nephropaty), uric acid level and acid-base homeostasis. Recently, there have been found some genes responsible for monogenic hereditary diseases such as ADPKD (PKD1 e PKD2) and Alport syndrome (COL4A3/COL4A4/COL4A5). It is known that there's an important phenotypic heterogeneity among different patients with the same disease even in the same family because of incomplete penetrance [5]. Furthermore, it is well known that familiarity overbear all other risk factors in predicting the development of hypertension and its progression toward CKD. Many scientific findings show the link between some genetic polymorphisms (e.g ACE, adducin) and disease severity or development of various complications. There is now, increasingly scientific evidence that genetic palys an important role even in the development and progression of multifactorial renal disease with both protective or promoting possible pathways. Thus, It would seem that interactions between environmental and genetic factors are responsible for disease phenotypic heterogeneity and its progression.
Aim of the study:
- Extend the knowledge on genetic modifiers involved in disease progression to better classify patients in homogeneous groups based on aetiology and concomitant risk factors. According to the underlying pathology, patients will be assessed either alone or with their family to evaluate the phenotypic heterogeneity.
- Evaluate the role of drugs that targets genetic or environmental factors.
- Assess the role of gentic background in the development of CV complications in CKD patients undergoing dyalisis.
- Assess the role of immature progenitor cells in the progression of kidney disease.
- Evaluate the role of endogenous Ouabain to identify at increased risk for AKI: 1) Postoperative patients. 2) patients with decompensated heart failure undergoing surgery or PCI. 3) patients with severe hypovolemic shock due to either cardiologic causes (e.g AMI) or from other causes (e.g sepsis, hypertensive crisis) 4) patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation.
- Identify the presence of genetic modifiers influencing the development and progression of CKD.
- Evaluate the role of genetic polymorphism in the transition from hypertension to kidney disease.
- Assess the role of salt intake in BP control and CKD progression either alone or in the presence of genetic modifiers.
- Evaluate the role of protein intake restriction in CKD progression eitehr alone or in the presence of genetic modifiers.
- Identify cortical bone lesions in CKD
- Assess the role of genetic, nutritional and biochemical factors involved in the cortical bone development
- Evaluate the role of genetic in the development of hypertension in patients who received allogenic bone marrow transplantation.
The genetic polymorphisms that will be considered, based on current knowledge are:
- Alpha, beta, gamma Adducin (ADD1, ADD2, ADD3),
- Renin Angiotensin System (RAAS),
- Glomerular proteins: nephrine, podocin, cadherin.
- Renal tubular transport systems (Na-Cl cotransport, Na channel, lithium, Cl channel, K channel, Ca channel, Amino Acids, specialized tubular transporters ouabain, drugs, digoxin, aquaporins, ANP, BNP).
- Genes linked to the metabolism and function of endogenous ouabain (eg LSS) and Klotho (eg KL).
- Polycystin 1, polycystin 2 (PKD1 and PKD2), uromodulline, S. di Alport (COL4A3/COL4A4/COL4A5)
For the study of any further genetic polymorphisms, additional amendments to this research protocol will be formulated.
- Conditions
- AKI, CKD, Ckd-Mbd, CKD (Chronic Kidney Disease) Stage 5D, ADPKD, Hypertension
- Being tested
- genetic polymorphisms
- Keywords
- genetic in hypertensive kidney disease, salt intake in BP control and CKD progression, genetic in CKD, endogenous Ouabain as marker of AKI, protein intake restriction in CKD progression, hypertension in allogenic bone marrow transplantation
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder, Renal Insufficiency, Chronic, Polycystic Kidney, Autosomal Dominant, Hypertension, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic polymorphismsGenetic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: genetic polymorphisms |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in glomerular filtration rate according to genetic profile
eGFR value
Measured: from days to 35 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start19 May 2006
- Primary completion19 May 2040 (estimated)
- Study completion19 May 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Lanzani, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416761
- Sponsor's protocol ID
- GenNefro01
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetic Contribution to Progression of Kidney Disease
- ClinicalTrials.gov ID
- NCT06416761
- Acronym / sponsor ID
- GenNefro01
- Conditions
- AKI, CKD, Ckd-Mbd, CKD (Chronic Kidney Disease) Stage 5D, ADPKD, Hypertension
- Keywords
- genetic in hypertensive kidney disease, salt intake in BP control and CKD progression, genetic in CKD, endogenous Ouabain as marker of AKI, protein intake restriction in CKD progression, hypertension in allogenic bone marrow transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 19 May 2006 (actual)
- Primary completion
- 19 May 2040 (estimated)
- Study completion
- 19 May 2041 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background: In the past ten years there's been a progressive increase in the prevalence of CKD and consequently in the number of dialysed patients (~4% per year) in Italy. This is probably due to the increasingly ageing population and incidence of CV disease (cf. Lombardy Register). To date, diabetes and CV disease are the most common cause of end-stage renal disease (ESRD) requiring RRT. Nonetheless, intrinsic renal diseases still remain an important cause of CKD. In the past few years, various environmental factors have been identified that affect the clinical progression of kidney disease: blood pressure control, lipid and glycemic profile (expecially in the setting of diabetic nephropaty), uric acid level and acid-base homeostasis. Recently, there have been found some genes responsible for monogenic hereditary diseases such as ADPKD (PKD1 e PKD2) and Alport syndrome (COL4A3/COL4A4/COL4A5). It is known that there's an important phenotypic heterogeneity among different patients with the same disease even in the same family because of incomplete penetrance [5]. Furthermore, it is well known that familiarity overbear all other risk factors in predicting the development of hypertension and its progression toward CKD. Many scientific findings show the link between some genetic polymorphisms (e.g ACE, adducin) and disease severity or development of various complications. There is now, increasingly scientific evidence that genetic palys an important role even in the development and progression of multifactorial renal disease with both protective or promoting possible pathways. Thus, It would seem that interactions between environmental and genetic factors are responsible for disease phenotypic heterogeneity and its progression.
Aim of the study:
- Extend the knowledge on genetic modifiers involved in disease progression to better classify patients in homogeneous groups based on aetiology and concomitant risk factors. According to the underlying pathology, patients will be assessed either alone or with their family to evaluate the phenotypic heterogeneity.
- Evaluate the role of drugs that targets genetic or environmental factors.
- Assess the role of gentic background in the development of CV complications in CKD patients undergoing dyalisis.
- Assess the role of immature progenitor cells in the progression of kidney disease.
- Evaluate the role of endogenous Ouabain to identify at increased risk for AKI: 1) Postoperative patients. 2) patients with decompensated heart failure undergoing surgery or PCI. 3) patients with severe hypovolemic shock due to either cardiologic causes (e.g AMI) or from other causes (e.g sepsis, hypertensive crisis) 4) patients with hematologic cancer exposed to chemotherapeutic agents or undergoing allogeneic bone marrow transplantation.
- Identify the presence of genetic modifiers influencing the development and progression of CKD.
- Evaluate the role of genetic polymorphism in the transition from hypertension to kidney disease.
- Assess the role of salt intake in BP control and CKD progression either alone or in the presence of genetic modifiers.
- Evaluate the role of protein intake restriction in CKD progression eitehr alone or in the presence of genetic modifiers.
- Identify cortical bone lesions in CKD
- Assess the role of genetic, nutritional and biochemical factors involved in the cortical bone development
- Evaluate the role of genetic in the development of hypertension in patients who received allogenic bone marrow transplantation.
The genetic polymorphisms that will be considered, based on current knowledge are:
- Alpha, beta, gamma Adducin (ADD1, ADD2, ADD3),
- Renin Angiotensin System (RAAS),
- Glomerular proteins: nephrine, podocin, cadherin.
- Renal tubular transport systems (Na-Cl cotransport, Na channel, lithium, Cl channel, K channel, Ca channel, Amino Acids, specialized tubular transporters ouabain, drugs, digoxin, aquaporins, ANP, BNP).
- Genes linked to the metabolism and function of endogenous ouabain (eg LSS) and Klotho (eg KL).
- Polycystin 1, polycystin 2 (PKD1 and PKD2), uromodulline, S. di Alport (COL4A3/COL4A4/COL4A5)
For the study of any further genetic polymorphisms, additional amendments to this research protocol will be formulated.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute or chronic nephropathy | – | Genetic: genetic polymorphisms1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- . presence of specific renal disease
Key exclusion criteria (1 listed)
- to be evaluated in the different sub-protocols
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic polymorphisms | Genetic | Patients with acute or chronic nephropathy |
Primary outcome
difference in glomerular filtration rate according to genetic profile
Time frame: from days to 35 years
eGFR value
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AKI and CKD, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Livia Lanzani, prof (+393408163279, lanzani.chiara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in glomerular filtration rate according to genetic profile (time frame: from days to 35 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.