Chronic Kidney Allograft NephropathyPhase 4NCT04769778
Renin Angiotensin System Blockade in Renal Transplant Patients With Presence of PECs in Urine
A Phase 4 study testing Valsartan 80Mg Oral Tablet in people with Chronic Kidney Allograft Nephropathy, run by Josep M Cruzado at 1 site in Spain.
Trial summary
By means of a personalized medicine strategy, investigators are going to evaluate if the treatment with an angiotensin II receptor antagonist (ARAII) in renal transplant patients with the presence of renal progenitor cells (PECs) in the urine is able to prevent the expected loss of glomerular filtration (GFR) observed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Allograft Nephropathy
- What is being tested?
- Valsartan 80Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 19 Feb 2020to Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- Written informed consent
- Stable renal function understood as a variation of eGFR of less than 15% in the last 3 months
- Immunosuppression maintenance based on tacrolimus and MMF / MPA
Who cannot join
- Chronic active infection by HCV, HBV, HIV.
- Treatment with inhibitors of the renin angiotensin system.
- Double kidney transplant or combined with another organ.
- Immunosuppression of maintenance other than tacrolimus and MMF / MPA.
- eGFR <20 ml / min / 1.73m2.
- History of allergy or intolerance to inhibitors of the renin angiotensin system.
Show all 9Show fewer
- Physically fertile women who plan to become pregnant, are pregnant and
- / or breast-feeding, or who do not want to use effective contraception during their participation in the study.
- Any other medical condition that, in the opinion of the investigator, based on the counting or review of clinical records, could affect the completion of the study, including, but not limited to, visual problems or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Nephrology Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Josep M Cruzado, Medical Doctor, 0034932607602, 27541jcg@comb.es
CAROLINA POLO, PhD, 932607385, cpolo@idibell.cat
About this study
By means of a personalized medicine strategy, investigators are going to evaluate if the treatment with an angiotensin II receptor antagonist (ARAII) in renal transplant patients with the presence of renal progenitor cells (PECs) in the urine is able to prevent the expected loss of glomerular filtration (GFR) observed in this subgroup of patients. In addition, investigators intend to deepen the mechanisms of glomerular damage and glomerular repair involved in the process of chronic allograft damage.
Read the detailed description
A randomized, double-blind clinical trial will be performed in renal transplant patients in month 6 post-transplant, at the time of protocol renal biopsy. After verifying the inclusion and exclusion criteria, informed consent will be obtained. Patients with urinary PECs will be randomized to 80 mg of valsartan vs. placebo (sample size calculated for a superiority study, 45 patients per group). Patients without PECs in urine will be followed according to usual clinical practice. The follow-up will be up to 2 years post-transplant. At baseline (6 m post-transplant) and at 2 years the GFR will be measured by means of iohexol clearance (main variable) and, in addition, we will analyze safety variables such as patient and graft survival and RAGIs. By means of morphometry techniques on renal biopsy and by measuring the renal cortical volume by high resolution CT, the number of glomeruli will be determined, which in turn, will allow to calculate the SN-GFR. Finally, in 5 patients per study group and in 5 controls, PECs of renal tissue will be isolated by means of laser microdissection techniques to perform single-cell RNA sequencing techniques to assess the molecular pathways involved in the glomerular damage and repair process and how the RAAS blockade modifies such molecular pathways.
- Conditions
- Chronic Kidney Allograft Nephropathy
- Being tested
- Valsartan 80Mg Oral Tablet
- Keywords
- renin angiotensin, kidney transplant, PEC's
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan 80Mg Oral TabletDrug
treatment with 80mg /day of valsartan
| Study group | Role | What they receive |
|---|---|---|
| Valsartan | Experimental | Treatment with valsartan Receives: Drug: Valsartan 80Mg Oral Tablet |
| no treatment | No intervention | no treatment received |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of fall of glomerular filtration rate
To assess whether treatment with an angiotensin II receptor antagonist (AIIRA) prevents the fall of glomerular filtration in the subgroup of kidney transplant patients with presence of PECs in urine.
Measured: 12 months
Secondary outcomes (8)
SN-GFR
Compare the SN-GFR (nephron glomerular filtration rate)
Measured: 12 months
Single cell RNA sequencing
Carry out single cell RNA sequencing studies using cell microdissection techniques of PEC cells isolated from renal biopsies performed at 6 and 24 m after transplantation in patients without uPECs and in patients with uPECs included in the therapeutic intervention study. These studies will allow us to know the changes of gene expression in PECS cells that can be associated with the favorable response in treated or untreated patients.
Measured: 12 months
podocyturia
To determine the influence of the treatment on podocyturia and the preservation of the number of podocytes at 2 years post transplant.
Measured: 12 months
graft survival
Evaluate the influence of treatment on graft survival
Measured: 12 months
patient survival
Evaluate the influence of treatment on patient survival and proteinuria.
Measured: 12 months
Chronic Glomerular Lessions
Evaluate the influence of treatment on number of participants with chronic glomerular lesions.
Measured: 12 months
Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting unexpected serious adverse reactions)
Evaluate the safety of the treatment on the number of patients with Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting unexpected serious adverse reactions) unexpected adverse reactions) and rate of treatment discontinuations.
Measured: 12 months
Proteinuria
Evaluate the influence of treatment on measure of proteinuria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start19 Feb 2020
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Allograft NephropathyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment with valsartan versus no treatment
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josep M Cruzado
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep M Cruzado, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769778
- Sponsor's protocol ID
- PRONE
- Status last verified
- May 2021
- First submitted
- 7 Jan 2021
- Last updated
- 19 May 2021
- 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 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renin Angiotensin System Blockade in Renal Transplant Patients With Presence of PECs in Urine
- ClinicalTrials.gov ID
- NCT04769778
- Acronym / sponsor ID
- PRONE
- Conditions
- Chronic Kidney Allograft Nephropathy
- Keywords
- renin angiotensin, kidney transplant, PEC's
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Josep M CruzadoUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Feb 2021 (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.
By means of a personalized medicine strategy, investigators are going to evaluate if the treatment with an angiotensin II receptor antagonist (ARAII) in renal transplant patients with the presence of renal progenitor cells (PECs) in the urine is able to prevent the expected loss of glomerular filtration (GFR) observed in this subgroup of patients. In addition, investigators intend to deepen the mechanisms of glomerular damage and glomerular repair involved in the process of chronic allograft damage.
Detailed description
A randomized, double-blind clinical trial will be performed in renal transplant patients in month 6 post-transplant, at the time of protocol renal biopsy. After verifying the inclusion and exclusion criteria, informed consent will be obtained. Patients with urinary PECs will be randomized to 80 mg of valsartan vs. placebo (sample size calculated for a superiority study, 45 patients per group). Patients without PECs in urine will be followed according to usual clinical practice. The follow-up will be up to 2 years post-transplant. At baseline (6 m post-transplant) and at 2 years the GFR will be measured by means of iohexol clearance (main variable) and, in addition, we will analyze safety variables such as patient and graft survival and RAGIs. By means of morphometry techniques on renal biopsy and by measuring the renal cortical volume by high resolution CT, the number of glomeruli will be determined, which in turn, will allow to calculate the SN-GFR. Finally, in 5 patients per study group and in 5 controls, PECs of renal tissue will be isolated by means of laser microdissection techniques to perform single-cell RNA sequencing techniques to assess the molecular pathways involved in the glomerular damage and repair process and how the RAAS blockade modifies such molecular pathways.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment with valsartan versus no treatment
| Arm | Type | Receives |
|---|---|---|
| Valsartan | Experimental | Drug: Valsartan 80Mg Oral TabletTreatment with valsartan |
| no treatment | No intervention | –no treatment received |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Stable renal function understood as a variation of eGFR of less than 15% in the last 3 months
- Immunosuppression maintenance based on tacrolimus and MMF / MPA
Key exclusion criteria (9 listed)
- Chronic active infection by HCV, HBV, HIV.
- Treatment with inhibitors of the renin angiotensin system.
- Double kidney transplant or combined with another organ.
- Immunosuppression of maintenance other than tacrolimus and MMF / MPA.
- eGFR <20 ml / min / 1.73m2.
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 |
|---|---|---|
| Valsartan 80Mg Oral Tablettreatment with 80mg /day of valsartan | Drug | Valsartan |
Primary outcome
prevention of fall of glomerular filtration rate
Time frame: 12 months
To assess whether treatment with an angiotensin II receptor antagonist (AIIRA) prevents the fall of glomerular filtration in the subgroup of kidney transplant patients with presence of PECs in urine.
8 secondary outcomes
SN-GFR
Time frame: 12 months
Single cell RNA sequencing
Time frame: 12 months
podocyturia
Time frame: 12 months
graft survival
Time frame: 12 months
patient survival
Time frame: 12 months
Chronic Glomerular Lessions
Time frame: 12 months
Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting unexpected serious adverse reactions)
Time frame: 12 months
Proteinuria
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Related trials for Chronic Kidney Allograft Nephropathy
Not yet recruitingPhase 3
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
Kidney Transplant Rejection
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
Chronic Kidney Diseases, Bladder Dysfunction
RecruitingObservational study
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
End-Stage Renal Disease
Not yet recruitingObservational study
Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function
End Stage Chronic Renal Failure, Renal Transplant
RecruitingObservational study
Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN)
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valsartan 80Mg Oral Tablet in people with Chronic Kidney Allograft Nephropathy, run by Josep M Cruzado at 1 site in Spain.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 May 2021. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JOSEP M CRUZADO, MD, PhD (932607385, jmcruzado@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of fall of glomerular filtration rate (time frame: 12 months). 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 19 May 2021.