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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00738257 |
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Date of registration:
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18/08/2008 |
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Primary sponsor: |
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Public title:
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A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.
SMART |
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Scientific title:
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A 2 Year Prospective, Multicentre, Open-label, Randomised, Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients (With a PTH > 150pg/ml) on a Ciclosporin A and Glucocorticoid Based Immunosuppressive Regimen. |
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Date of first enrolment:
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June 2000 |
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Target sample size:
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126 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00738257 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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John Cunningham, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal London Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. First or second kidney transplant recipients, aged 18-75 years, PTH > 150 pg/ml
2. De novo patients scheduled to receive ciclosporin A and prednisolone based
immunosuppression.
Exclusion Criteria:
1. Previous or current bone disease unrelated to end stage renal failure.
2. Patients with PTH < 150pg/ml who may be at risk of adynamic bone disease.
3. Treatment at any time with a bisphosphonate.
4. d. Calcitonin treatment during the previous month.
5. Malignancy (current or history within last 5 years)
6. Pregnancy or lactation, or women of childbearing potential unwilling to use an
effective form of contraception for the 12 month duration of the study.
Protocol-defined inclusion/exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bone Loss
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Intervention(s)
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Drug: Pamidronate
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Secondary ID(s)
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ARE-GB-01
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NEO-GB-50
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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