Cytomegalovirus InfectionsNCT04906304
Comparison of Safety and Efficacy of de Novo Everolimus
A study testing Everolimus Pill and Sandimmun (Neoral) dose plus cellcept in people with Cytomegalovirus Infections, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Nowadays, de novo everolimus regimen in renal transplant patients is considered for reduction of cyclosporine dose and it is mentioned that this regimen not only has similar safety and efficacy, but also could prevent Cytomegalovirus (CMV )infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Everolimus Pill and Sandimmun (Neoral) dose plus cellcept
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2020to 1 Aug 2020
- Phase
- Interventional
- 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
- Adult Transplanted patients > 18 years
Who cannot join
- Simultanous Kidney -Pancreas Transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Safety and Efficacy of de Novo Everolimus Plus Low Dose of Cyclosporine With Standard Dose of Cyclosporine Plus Cellcept on CMV and BK Virus Infections Prevention in Renal Transplant Patients
Nowadays, de novo everolimus regimen in renal transplant patients is considered for reduction of cyclosporine dose and it is mentioned that this regimen not only has similar safety and efficacy, but also could prevent Cytomegalovirus (CMV )infections. So, the aim of this study was comparison of safety and efficacy of de novo everolimus plus low dose of cyclosporine with standard dose of cyclosporine plus cellcept on CMV virus infections prevention in renal transplant patients.
Read the detailed description
This randomized clinical trial was conducted in Shahid Labbafi nejad hospital. 35 renal transplanted patients enter the study and randomized to one of two groups: everolimus or control (Sandimmun or tacrolimus). However, 34 patients completed study (17 patients in each group). The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose and in control group was standard dose of Sandimmun or tacrolimus plus cellcept. All patients gave Antithymocyte Glubolin and prednisolone. In addition, they gave CMV prophylaxis until 3 months. Kidney biopsies were done for raise of creatinine or protocol biopsy at 6 month after transplantation. Demographic, renal disease and transplantation characteristics, CMV and BK virus status, rejection, and routine laboratory tests recorded during study period and compared between two groups.
- Conditions
- Cytomegalovirus Infections
- Being tested
- Everolimus Pill, Sandimmun (Neoral) dose plus cellcept
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus PillDrug
Also called Novartis
standard dose versus low dose Sandimun
Sandimmun (Neoral) dose plus cellceptDrug
Sandimmun (Neoral) dose plus cellcept
| Study group | Role | What they receive |
|---|---|---|
| Evrolimus | Experimental | The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose pluse cellcept Receives: Drug: Everolimus Pill; Drug: Sandimmun (Neoral) dose plus cellcept |
| Control | Active comparator | 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept Receives: Drug: Everolimus Pill; Drug: Sandimmun (Neoral) dose plus cellcept |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV Infection
CMV PCR quantitative count
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Jan 2020
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- SBMU University of Medical Sciences, Study director, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906304
- Sponsor's protocol ID
- UNRC940401/18
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy of de Novo Everolimus Plus Low Dose of Cyclosporine With Standard Dose of Cyclosporine Plus Cellcept on CMV and BK Virus Infections Prevention in Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT04906304
- Acronym / sponsor ID
- UNRC940401/18
- Conditions
- Cytomegalovirus Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 28 May 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.
Nowadays, de novo everolimus regimen in renal transplant patients is considered for reduction of cyclosporine dose and it is mentioned that this regimen not only has similar safety and efficacy, but also could prevent Cytomegalovirus (CMV )infections. So, the aim of this study was comparison of safety and efficacy of de novo everolimus plus low dose of cyclosporine with standard dose of cyclosporine plus cellcept on CMV virus infections prevention in renal transplant patients.
Detailed description
This randomized clinical trial was conducted in Shahid Labbafi nejad hospital. 35 renal transplanted patients enter the study and randomized to one of two groups: everolimus or control (Sandimmun or tacrolimus). However, 34 patients completed study (17 patients in each group). The treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose and in control group was standard dose of Sandimmun or tacrolimus plus cellcept. All patients gave Antithymocyte Glubolin and prednisolone. In addition, they gave CMV prophylaxis until 3 months. Kidney biopsies were done for raise of creatinine or protocol biopsy at 6 month after transplantation. Demographic, renal disease and transplantation characteristics, CMV and BK virus status, rejection, and routine laboratory tests recorded during study period and compared between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evrolimus | Experimental | Drug: Everolimus Pill, Drug: Sandimmun (Neoral) dose plus cellceptThe treatment regimen in everolimus group was 0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral) low dose pluse cellcept |
| Control | Active comparator | Drug: Everolimus Pill, Drug: Sandimmun (Neoral) dose plus cellcept0.75 mg/bid everolimus with everolimus C0 3-8 ng/mL plus Sandimmun (Neoral)standard dose plus cellcept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Transplanted patients > 18 years
Key exclusion criteria (1 listed)
- Simultanous Kidney -Pancreas Transplantation
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 |
|---|---|---|
| Everolimus PillAlso: Novartisstandard dose versus low dose Sandimun | Drug | Control, Evrolimus |
| Sandimmun (Neoral) dose plus cellceptSandimmun (Neoral) dose plus cellcept | Drug | Control, Evrolimus |
Primary outcome
CMV Infection
Time frame: 6 months
CMV PCR quantitative count
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
SBMU University of Medical Sciences study director
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everolimus Pill and Sandimmun (Neoral) dose plus cellcept in people with Cytomegalovirus Infections, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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: finished, as of the sponsor's last update on 28 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV Infection (time frame: 6 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 28 May 2021.