Transplantation, KidneyPhase 1NCT00617474
The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group
A Phase 1 study testing Erythropoietin in people with Transplantation, Kidney, run by Labbafinejhad Hospital.
Trial summary
The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplantation, Kidney
- What is being tested?
- Erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Mar 2009
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hb: >8 and <10 gr/dl
- Age: >18 and <55 years
- Cholesterol: <300 mg/dl
- Triglyceride: <400 mg/dl
- First Transplantation
- Protocol of Immunosuppression: CSA + MMF + Prednisolone
- Systolic BP: <14
- Diastolic BP: <9
Who cannot join
- History of specified cardiac disease
- Second Transplantation or more
- Hb: <7gr/dl
- The patient needs to infusion of blood
- Evidence of local or systemic infection, at the time of EPO injection
- Presence of ATN / DGF after transplantation
Show all 9Show fewer
- Presence of emergent hypertension
- High risk patients ( Like; PRA>50%)
- Past history of hypersensitivity
About this study
The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival.
- Conditions
- Transplantation, Kidney
- Being tested
- Erythropoietin, Placebo
- Keywords
- erythropoietin, kidney allograft survival, Recombinant Erythropoietin, erythropoietin (Epo)-induced protein 29, human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
sub cutaneous injection, 2000 unit in per injection, 3 times 1 week.
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group of patient with anemia, that treated by erythropoietin Receives: Drug: Erythropoietin |
| 2 | Placebo comparator | Patients group with anemia that treated by placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will study the well-being of renal function by evaluation of plasma Cr,GFR,PTDA scan & biopsy proven(If it is necessary to prove the rejection)about measuring of patient - graft survival.
Measured: May,2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation, KidneyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Labbafinejhad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617474
- Sponsor's protocol ID
- L1386
- Other IDs
- 200786
- Status last verified
- Mar 2008
- First submitted
- 6 Feb 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group
- ClinicalTrials.gov ID
- NCT00617474
- Acronym / sponsor ID
- L1386
- Conditions
- Transplantation, Kidney
- Keywords
- erythropoietin, kidney allograft survival, Recombinant Erythropoietin, erythropoietin (Epo)-induced protein 29, human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Labbafinejhad HospitalUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 18 Feb 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.
The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ErythropoietinGroup of patient with anemia, that treated by erythropoietin |
| 2 | Placebo comparator | Drug: PlaceboPatients group with anemia that treated by placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Hb: >8 and <10 gr/dl
- Age: >18 and <55 years
- Cholesterol: <300 mg/dl
- Triglyceride: <400 mg/dl
- First Transplantation
Key exclusion criteria (9 listed)
- History of specified cardiac disease
- Second Transplantation or more
- Hb: <7gr/dl
- The patient needs to infusion of blood
- Evidence of local or systemic infection, at the time of EPO injection
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 |
|---|---|---|
| Erythropoietinsub cutaneous injection, 2000 unit in per injection, 3 times 1 week. | Drug | 1 |
| Placeboplacebo | Drug | 2 |
Primary outcome
We will study the well-being of renal function by evaluation of plasma Cr,GFR,PTDA scan & biopsy proven(If it is necessary to prove the rejection)about measuring of patient - graft survival.
Time frame: May,2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erythropoietin in people with Transplantation, Kidney, run by Labbafinejhad Hospital.
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 8 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 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
We will study the well-being of renal function by evaluation of plasma Cr,GFR,PTDA scan & biopsy proven(If it is necessary to prove the rejection)about measuring of patient - graft survival. (time frame: May,2008). 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 Mar 2008.