Kidney TansplantNCT00395902
Post Transplant Study
An observational study of Kidney Tansplant and Secondary Hyperparathyroidism, run by Amgen.
Trial summary
Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tansplant, Secondary Hyperparathyroidism, Hyperparathyroidism
- What is being tested?
- Sensipar after Post Transplant
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to not given
- Phase
- Observational
- 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
- Adult, Older adult
Who may be able to join
- Adults >= 18 years old
- Subjects who have received Sensipar for a duration of at least 3 months, beginning at least 3 months after a kidney transplant. Subjects must have begun Sensipar teatment no later than Februry 28, 2005 at treating physician's discretion.
Who cannot join
- Subjects who received Sensipar before undergoing a kidney transplant
- Subjects receiving dialysis post-transplant
About this study
Official title: A Retrospective Evaluation of Sensipar Use in Renal Transplant Recipients
Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients
- Being tested
- Sensipar after Post Transplant
- Keywords
- Sensipar, cinacalcet, Mimpara
- Medical subject headings
- Hyperparathyroidism, Secondary, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensipar after Post TransplantDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TansplantStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395902
- Sponsor's protocol ID
- 20040261
- Other IDs
- 2004261
- Status last verified
- Dec 2007
- First submitted
- 2 Nov 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Evaluation of Sensipar Use in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT00395902
- Acronym / sponsor ID
- 20040261
- Keywords
- Sensipar, cinacalcet, Mimpara
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 6 Nov 2006 (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.
Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults >= 18 years old
- Subjects who have received Sensipar for a duration of at least 3 months, beginning at least 3 months after a kidney transplant. Subjects must have begun Sensipar teatment no later than Februry 28, 2005 at treating physician's discretion.
Key exclusion criteria (2 listed)
- Subjects who received Sensipar before undergoing a kidney transplant
- Subjects receiving dialysis post-transplant
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 |
|---|---|---|
| Sensipar after Post Transplant | Drug | – |
Primary outcome
Not reported in the source record.
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 Dec 2007.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Kidney Tansplant
RecruitingObservational study
Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients
Hemodyalysis, Kidney Tansplant
Recruiting
Daratumumab for Late Antibody-Mediated Rejection
Kidney Tansplant, Acute Rejection (AR) of Transplanted Kidney
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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Tansplant and Secondary Hyperparathyroidism, run by Amgen.
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 2 inclusion and 2 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 Dec 2007. 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. 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.
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 Dec 2007.