Posts Tagged ‘randomized controlled trial’

November 28, 2013

Planned Randomized Conversion From Tacrolimus to Sirolimus-Based Immunosuppressive Regimen in De Novo Kidney Transplant Recipients


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While sirolimus has some features that make it an attractive immunosuppressant, it is less effective at preventing acute rejection than calcineurin inhibitors (CnI). An alternate strategy is to use CnI early post-transplant and then switch to sirolimus at some point post-transplant. In this randomized controlled trial, patients with good graft function and no other contraindications […]

No Comments Posted in Renal Transplantation
August 30, 2013

Improving Outcomes of Renal Transplant Recipients With Behavioral Adherence Contracts: A Randomized Controlled Trial


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Non-adherence is a well-recognized risk factor for adverse events post-transplant, but there have been few interventions aimed at improving adherence. In this randomized controlled trial, regular interaction with a pharmacist and a contract laying out behaviours required of the patient improved adherence, as measured by medication refills. It also resulted in fewer hospitalization.

No Comments Posted in Renal Transplantation, Uncategorized
June 21, 2013

Oral Paricalcitol Reduces the Prevalence of Posttransplant Hyperparathyroidism: Results of an Open Label Randomized Trial


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Bone disease and secondary hyperparathyroidism are common following renal transplantation. This open-label randomized controlled trial compared the calcitriol analog paricalcitol to placebo, with a primary endpoint of hyperparathyroidism at one year post-transplant. There was less hyperparathyroidism in the paricalcitol-treated group. However, there was no difference in bone density between groups. Also, these patients were not […]

No Comments Posted in Renal Transplantation
June 21, 2013

Efficacy of Sotrastaurin Plus Tacrolimus After De Novo Kidney Transplantation: Randomized, Phase II Trial Results


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New immunosuppressant agents face a high standard: theymust show comparable or superior results as current treatments with less side effects. Sotrastaurin is an oral medication that blocks protein kinase C to prevent T cell activation. In this randomized controlled trial, sotrastaurin combined with tacrolimus, steroids and basiliximab showed similar rates of acute rejection and graft […]

No Comments Posted in Renal Transplantation
June 21, 2013

Controlled-Dose Versus Fixed-Dose Mycophenolate Mofetil for Kidney Transplant Recipients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials


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There have been several trials evaluating a strategy of adjusting mycophenolic acid dose early post-transplant based on pharmacokinetic studies early post-transplant as opposed to prescribing a fixed dose to all patients. This meta-analysis of available trials showed no reduction in acute rejection or graft loss with such a practice. There were also no differences in […]

No Comments Posted in Renal Transplantation
January 28, 2013

Angiotensin II Blockade in Kidney Transplant Recipients


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ACE-inhibitors and ARBs are a mainstay of treatment for patients with glomerular renal disease or proteinuria. In this randomized controlled trial, patients receiving a renal transplant were randomized to losartan or placebo. There was no difference in the primary endpoint, which was a composite of doubling of interstitial fibrosis on renal biopsy at five years […]

No Comments Posted in Renal Transplantation
January 28, 2013

Conversion From Twice-Daily Tacrolimus to Once-Daily Extended Release Tacrolimus (LCPT): The Phase III Randomized MELT Trial


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Advagraf, a once-daily extended-release tacrolimus formulation was released several years ago. Another once daily formulation of tacrolimus called LCPT, has now been developed. In this non-inferiority RCT, the LCPT formulation showed similar outcomes to standard twice-daily tacrolimus with a lower daily dose. The availability of multiple once-daily tacrolimus formulations, as well as several generic versions […]

No Comments Posted in Renal Transplantation
January 28, 2013

Angiotensin II Blockade in Kidney Transplant Recipients


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ACE-inhibitors and ARBs are a mainstay of treatment for patients with glomerular renal disease or proteinuria. In this randomized controlled trial, patients receiving a renal transplant were randomized to losartan or placebo. There was no difference in the primary endpoint, which was a composite of doubling of interstitial fibrosis on renal biopsy at five years […]

No Comments Posted in Renal Transplantation
January 28, 2013

Conversion From Twice-Daily Tacrolimus to Once-Daily Extended Release Tacrolimus (LCPT): The Phase III Randomized MELT Trial


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Advagraf, a once-daily extended-release tacrolimus formulation was released several years ago. Another once daily formulation of tacrolimus called LCPT, has now been developed. In this non-inferiority RCT, the LCPT formulation showed similar outcomes to standard twice-daily tacrolimus with a lower daily dose. The availability of multiple once-daily tacrolimus formulations, as well as several generic versions […]

No Comments Posted in Renal Transplantation
October 30, 2012

A 1-Year Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Ibandronate on Bone Loss Following Renal Transplantation


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Bone disease post-transplant is a common problem, related to pre-transplant bone disease as well as immunosuppression. This randomized controlled trial assessed the effect of adding IV ibandronate to a regimen of calcium and calcitriol in patients post-renal transplant. Surprisingly, there was no benefit on bone density in the lumbar spine compared to the control group, […]

No Comments Posted in Renal Transplantation