End Stage Renal DiseasePhase 4NCT00656695
Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation
A Phase 4 study testing Iminoral and Neoral in people with End Stage Renal Disease and Renal Transplantation, run by Imam Khomeini Hospital at 1 site in Iran.
Trial summary
Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more than 2500 new renal transplantation each year and because of this the government pay a huge amount of money for subsiding the imported cyclosporine in the form of Neoral. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Renal Transplantation
- What is being tested?
- Iminoral and Neoral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteIran
- Study dates
- Apr 2008to Oct 2009
- 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
- renal transplantation candidates
- written consent
- not taking participate in any other clinical trial in last 3 months
Who cannot join
- primary FSGS
- hyperoxaluria
- age under 18
- multi organ transplantation
- any malignancy in 5 years
- PRA > 25%
- use of Tacrolimus
- hyper acute rejection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison Between Clinical and Paraclinical Effect of Iminoral Vs Neoral in Prevention of Acute Rejection in the First Year Afer Transplantation in De Novo Renal Transplant Patients
Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more than 2500 new renal transplantation each year and because of this the government pay a huge amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an Iranian drug company introduced this drug in the name of Iminoral which has been approved by different authorities in Iran and abroad, (including the Ministry of Health in Iran and also European Directorate for the Quality of Medicines Certification Unit and FDA(Department of Health and Human Services,Center for Drug Evaluation and Research)). The investigators study is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing acute rejection in renal transplantation and also to compare the side effects of these two drugs.
- Conditions
- End Stage Renal Disease, Renal Transplantation
- Being tested
- Iminoral, Neoral
- Keywords
- Iminoral, Neoral, Acute renal transplant rejection
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IminoralDrug
Iminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
NeoralDrug
Neoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | taking Iminoral Receives: Drug: Iminoral |
| 2 | Active comparator | taking Neoral Receives: Drug: Neoral |
What is being measured
The primary outcome is the main question the study is designed to answer.
transplanted kidney acute rejection
Measured: one year
Secondary outcomes (1)
cyclosporine side effects
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Khomeini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Reza Khatami, Imam Khomeini Hospital
- Investigators
- Mohammad R Khatami, MD, Principal investigator, Imam Khomeini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656695
- Sponsor's protocol ID
- iminoral
- Status last verified
- Jun 2012
- First submitted
- 7 Apr 2008
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khatami SM, Taheri S, Azmandian J, Sagheb MM, Nazemian F, Razeghi E, Shahidi S, Sadri F, Shamshiri AR, Sayyah M. One-Year Multicenter Double-Blind Randomized Clinical Trial on the Efficacy and Safety of Generic Cyclosporine (Iminoral) in De Novo Kidney Transplant Recipients. Exp Clin Transplant. 2015 Jun;13(3):233-8.
PubMed 26086833
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Between Clinical and Paraclinical Effect of Iminoral Vs Neoral in Prevention of Acute Rejection in the First Year Afer Transplantation in De Novo Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT00656695
- Acronym / sponsor ID
- iminoral
- Conditions
- End Stage Renal Disease, Renal Transplantation
- Keywords
- Iminoral, Neoral, Acute renal transplant rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Imam Khomeini HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Apr 2008 (estimated)
- 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.
Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more than 2500 new renal transplantation each year and because of this the government pay a huge amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an Iranian drug company introduced this drug in the name of Iminoral which has been approved by different authorities in Iran and abroad, (including the Ministry of Health in Iran and also European Directorate for the Quality of Medicines Certification Unit and FDA(Department of Health and Human Services,Center for Drug Evaluation and Research)). The investigators study is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing acute rejection in renal transplantation and also to compare the side effects of these two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Iminoraltaking Iminoral |
| 2 | Active comparator | Drug: Neoraltaking Neoral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- renal transplantation candidates
- written consent
- not taking participate in any other clinical trial in last 3 months
Key exclusion criteria (8 listed)
- primary FSGS
- hyperoxaluria
- age under 18
- multi organ transplantation
- any malignancy in 5 years
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 |
|---|---|---|
| IminoralIminoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily | Drug | 1 |
| NeoralNeoral in form of capsules 25,50 and 100 mg giving in the dose of 3-7 mg/kg twice daily | Drug | 2 |
Primary outcome
transplanted kidney acute rejection
Time frame: one year
1 secondary outcome
cyclosporine side effects
Time frame: one year
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 22 Jun 2012.
- Derived from this study: PubMed 26086833Khatami SM, Taheri S, Azmandian J, Sagheb MM, Nazemian F, Razeghi E, Shahidi S, Sadri F, Shamshiri AR, Sayyah M. One-Year Multicenter Double-Blind Randomized Clinical Trial on the Efficacy and Safety of Generic Cyclosporine (Iminoral) in De Novo Kidney Transplant Recipients. Exp Clin Transplant. 2015 Jun;13(3):233-8.
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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.
Mohammad R Khatami, MD principal investigator
Imam Khomeini Hospital
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 Iminoral and Neoral in people with End Stage Renal Disease and Renal Transplantation, run by Imam Khomeini Hospital 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 3 inclusion and 8 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 22 Jun 2012. 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.
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?
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?
transplanted kidney acute rejection (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00656695, which also lists 1 linked publication.
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 22 Jun 2012.