NEWS HIGHLIGHTSMedia Articles Related to Sandimmune (Cyclosporine)
600th Heart Attack Patient Recruited Into Phase III CicloMulsion® CIRCUS Trial
Source: Clinical Trials / Drug Trials News From Medical News Today [2013.03.27]
NeuroVive, a leading mitochondrial medicine company, announces that the 600th patient has been recruited to a pivotal Phase III European, multi-center trial (CIRCUS trial) assessing CicloMulsion® (a special formulation of cyclosporine for acute cardiac injuries) for the treatment of heart reperfusion injury following stenting in patients with myocardial infarction...
Published Studies Related to Sandimmune (Cyclosporine)
Effect of cyclosporine-A on orthodontic tooth movement in rats. [2011.11]
CONCLUSIONS: We suggest that CsA enhanced the rate of orthodontic tooth movement. The osteopenia and the increased osteoclastic activity could be the underlying factors. (c) 2011 John Wiley & Sons A/S.
Safety and toxicology of cyclosporine in propylene glycol after 9-month aerosol exposure to beagle dogs. [2011.08]
BACKGROUND: Cyclosporine inhalation solution (CIS) delivered via nebulization is under evaluation for the prevention of chronic rejection post-lung transplant. A 300-patient randomized, controlled clinical trial (CYCLIST) is expected to be completed late in 2011. In support of this trial, a chronic inhalation toxicology study in dogs has been completed... CONCLUSION: The study supports the pulmonary and systemic safety of aerosolized CIS at expected lung dose levels/kg of up to 12 times greater than the average dose patients are receiving in the CYCLIST trial.
Prospective, randomized study of the efficacy of systemic cyclosporine in high-risk corneal transplantation. [2011.07]
PURPOSE: Immunologic rejection remains a major cause of graft failure in high-risk corneal transplantation. This study was conducted to elucidate the efficacy and safety of systemic cyclosporine (CsA) in high-risk corneal transplantation. DESIGN: Prospective, randomized, open-labeled clinical trial with a parallel-group study... CONCLUSIONS: No positive effect of systemic CsA administration for suppressing rejection in high-risk corneal transplantation was observed. With a relatively high incidence of systemic side effects, the results suggest that this protocol should not be recommended for corneal transplant recipients, especially those of advanced age. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Belatacept-based regimens are associated with improved cardiovascular and metabolic risk factors compared with cyclosporine in kidney transplant recipients (BENEFIT and BENEFIT-EXT studies). [2011.05.15]
BACKGROUND: Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic risk profile than current immunosuppressants... CONCLUSIONS: At month 12, belatacept regimens were associated with better cardiovascular and metabolic risk profiles, with lower blood pressure and serum lipids and less NODAT versus CsA. The overall profile of belatacept will continue to be assessed over the 3-year trials.
A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. [2011.04.28]
We evaluated the role of granulocyte colony-stimulating factor (G-CSF) in patients with severe aplastic anemia (SAA) treated with antithymocyte globulin (ATG) and cyclosporine (CSA). Between January 2002 and July 2008, 192 patients with newly diagnosed SAA not eligible for transplantation were entered into this multicenter, randomized study to receive ATG/CSA with or without G-CSF...
Clinical Trials Related to Sandimmune (Cyclosporine)
Low Dose Cyclosporin A in Primary Sj�gren Syndrome [Recruiting]
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis [Not yet recruiting]
The objective of this study is to compare the efficacy of two different dosing regimen of
NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of
the formulation) administered four times a day in patients with severe vernal
keratoconjunctivitis after 4 months of treatment.
The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are
effective in rendering recent onset type 1 diabetes patients, insulin independent. This
four-arm study was designed to evaluate the safety and efficacy for insulin independence by
utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved
proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase
gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell
formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).
Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among
recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as
67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med.
1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further
autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was
ultimately required by all patients. Therefore, this study proposes the usage of
cyclosporine with a beta regeneration agent.
Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20
months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res
Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor
demonstrated reductions in daily insulin requirements by much as 75% within 3 months
following four weeks of therapy among existing type 1 diabetes patients (Transition
Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed
January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing
autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown
to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth
factor in in-vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).
Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune
tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been
successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci.
2007;1103: 19-32). The distinctions and complexities of islets in man are far different than
that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of
print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration
agent are required to sustain insulin independence.
Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to
10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This
study will determine the safety and efficacy of cyclosporine used with and without
lansoprazole to determine the impact on insulin independence among recently diagnosed
patients with type 1 diabetes.
Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The
combination of the two therapies may render reductions in insulin requirements and have a
greater impact on sustained insulin independence than previously reported with cyclosporine
or gastrin alone among type 1 patients.
This 12-week study consists of four treatment arms:
- Oral Cyclosporine/Placebo
- Oral Lansoprazole/Placebo
- Oral Lansoprazole/Oral Cyclosporine
- Oral Placebo/Oral Placebo
It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will
safely render significantly more patients with existing type 1 diabetes, insulin independent
and may serve as a novel and innovative treatment approach for recently diagnosed patients
with type 1 diabetes utilizing two FDA-approved therapies.
The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are
effective in rendering patients with existing type 1 diabetes, insulin independent. This
four-arm study was designed to evaluate the safety and efficacy for insulin independence by
utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved
proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase
gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell
formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).
Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among
recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as
67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med.
1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further
autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was
ultimately required by all patients. Therefore, this study proposes the usage of
cyclosporine with a beta regeneration agent.
Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20
months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res
Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor
demonstrated reductions in daily insulin requirements by much as 75% within 3 months
following four weeks of therapy among existing type 1 diabetes patients (Transition
Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed
January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing
autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown
to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth
factor in in vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).
Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune
tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been
successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci.
2007;1103: 19-32). The distinctions and complexities of islets in man are far different than
that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of
print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration
agent are required to sustain insulin independence.
Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to
10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This
study will determine the safety and efficacy of cyclosporine used with and without
lansoprazole to determine the impact on insulin independence among patients with existing
type 1 diabetes.
Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The
combination of the two therapies may render reductions in insulin requirements and have a
greater impact on sustained insulin independence than previously reported with cyclosporine
or gastrin alone among type 1 patients.
This 12-week study consists of four treatment arms:
- Oral Cyclosporine/Placebo
- Oral Lansoprazole/Placebo
- Oral Lansoprazole/Oral Cyclosporine
- Oral Placebo/Oral Placebo
It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will
safely render significantly more patients with existing type 1 diabetes, insulin independent
and may serve as a novel and innovative treatment approach for patients with type 1 diabetes
utilizing two FDA-approved therapies.
Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis [Recruiting]
Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated
with eczema. Over time, the complications from this disease process lead to loss of vision
due to continual scarring of the corneal surface. The pathophysiology of AKC has not been
fully elucidated, and the triggers are still unknown.
Corticosteroids are very effective in controlling the acute symptoms of AKC. However, two
thirds of patients managed with a combination of oral antihistamine, topical mast cell
stabilizer, and intermittent topical steroid regimen eventually developed significant
keratopathy and vision loss. Additionally, there are many side effects of corticosteroids,
including local immunosuppression, cataract formation, and increased risk of glaucoma.
Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the
expression of the interleukin-2 receptor. It also blocks the release of inflammatory
mediators from mast cells and eosinophils. Cyclosporin has no known side effects except for
burning upon instillation, and safe to use over long-term . The investigators have
demonstrated that a 0. 05% ophthalmic emulsion of cyclosporine has been shown to be effective
at improving the ocular signs and symptoms of AKC over short-term. However, the long-term
efficacy of cyclosporine A in slowing the natural history of AKC and possible steroid
sparing effects have not been assessed. The investigators hypothesize that cyclosporine A
can be used as a mainstay treatment of AKC to control signs and symptoms over a long period
of time and also prevent the progression of this disease.
Reports of Suspected Sandimmune (Cyclosporine) Side Effects
Thrombotic Microangiopathy (16),
Renal Impairment (13),
Pyrexia (11),
Cytomegalovirus Infection (11),
Renal Failure Acute (10),
Renal Failure (9),
Diarrhoea (9),
Multi-Organ Failure (8),
Blood Lactate Dehydrogenase Increased (8),
Atrial Fibrillation (8), more >>
|
