Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Urology, Urology |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 6/16/2016 |
| Start Date: | November 2013 |
| End Date: | April 2016 |
This is a study for patients that have a condition called Interstitial Cystitis, also known
as Painful Bladder Syndrome. Patients would have tried at least two different therapies,
unsuccessfully,(eg. medications, pelvic floor physical therapy)
The purpose of this research project is to study the immunosuppressive drug Cyclosporine in
patients with Interstitial Cystitis to assess how well it works, what the side effects are
and what is its mechanism of action. Cyclosporine is a drug that is FDA-approved to prevent
organ rejection after kidney, liver, and heart transplant but is not approved by the FDA for
Interstitial Cystitis. Several research studies have been published showing that
Cyclosporine can improve the symptoms of Interstitial Cystitis, that it works better than a
placebo ("sugar pill" or inert treatment) and that it works more effectively than Pentosan
Polysulfate (Elmiron), which is an FDA approved therapy. The dose of Cyclosporine used in
these studies on Interstitial Cystitis are much lower that the doses used to prevent
rejection in transplant patients.
Based on these studies, the American Urological Association has recently published treatment
guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure
of other more conservative therapies and medications. Nevertheless, much is not known about
using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the
ideal dose, how best to monitor for side effects and in particular whether kidney damage can
occur at the low doses used in these studies. In this study, to examine the mechanism of
action, blood and urine samples will be collected before, during and after therapy to look
at "biomarkers", chemical substances that can be associated with inflammation and tissue
injury. We will also test effects of therapy on skin sensation and pain perception because
the molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct
pain signals.
This study is only being done at the Cleveland Clinic and will involve about 30 patients
with Interstitial Cystitis.
as Painful Bladder Syndrome. Patients would have tried at least two different therapies,
unsuccessfully,(eg. medications, pelvic floor physical therapy)
The purpose of this research project is to study the immunosuppressive drug Cyclosporine in
patients with Interstitial Cystitis to assess how well it works, what the side effects are
and what is its mechanism of action. Cyclosporine is a drug that is FDA-approved to prevent
organ rejection after kidney, liver, and heart transplant but is not approved by the FDA for
Interstitial Cystitis. Several research studies have been published showing that
Cyclosporine can improve the symptoms of Interstitial Cystitis, that it works better than a
placebo ("sugar pill" or inert treatment) and that it works more effectively than Pentosan
Polysulfate (Elmiron), which is an FDA approved therapy. The dose of Cyclosporine used in
these studies on Interstitial Cystitis are much lower that the doses used to prevent
rejection in transplant patients.
Based on these studies, the American Urological Association has recently published treatment
guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure
of other more conservative therapies and medications. Nevertheless, much is not known about
using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the
ideal dose, how best to monitor for side effects and in particular whether kidney damage can
occur at the low doses used in these studies. In this study, to examine the mechanism of
action, blood and urine samples will be collected before, during and after therapy to look
at "biomarkers", chemical substances that can be associated with inflammation and tissue
injury. We will also test effects of therapy on skin sensation and pain perception because
the molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct
pain signals.
This study is only being done at the Cleveland Clinic and will involve about 30 patients
with Interstitial Cystitis.
Based on these studies, the American Urological Association has recently published treatment
guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure
of other more conservative therapies and medications. Nevertheless, much is not known about
using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the
ideal dose, how best to monitor for side effects and in particular whether kidney damage can
occur at the low doses used in these studies. In this study, to examine the mechanism of
action, blood and urine samples will be collected before, during and after therapy to look
at "biomarkers", chemical substances that can be associated with inflammation and tissue
injury. We will also test effects of therapy on skin sensation and pain perception because
the molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct
pain signals.
This study is only being done at the Cleveland Clinic and will involve about 30 patients
with Interstitial Cystitis.
guidelines that recommend Cyclosporine therapy for Interstitial Cystitis after the failure
of other more conservative therapies and medications. Nevertheless, much is not known about
using Cyclosporine therapy for Interstitial Cystitis including the mechanism of action, the
ideal dose, how best to monitor for side effects and in particular whether kidney damage can
occur at the low doses used in these studies. In this study, to examine the mechanism of
action, blood and urine samples will be collected before, during and after therapy to look
at "biomarkers", chemical substances that can be associated with inflammation and tissue
injury. We will also test effects of therapy on skin sensation and pain perception because
the molecule which Cyclosporine binds to (calcineurin) is also found in nerves that conduct
pain signals.
This study is only being done at the Cleveland Clinic and will involve about 30 patients
with Interstitial Cystitis.
Inclusion Criteria:
1. age > 18
2. able to give consent
3. commitment to return for follow up appointments
4. agree to all parts of the study, including pain sensation testing
5. total ICSI score >9
Exclusion Criteria:
1. active cancer
2. history of pelvic radiation
3. history of previous urological malignancy
4. serum Cr > 1.5 mg/dl
5. diagnosis of diabetes mellitus types I or II
6. untreated hypertension or blood pressure on treatment > 140/90
7. proteinuria at enrollment
8. current or previous urinary diversion or bladder augmentation
9. chronic use of a medication class with significant impact on CyA blood levels (eg.
macrolide antibiotics, phenytoin, oral antifungals, calcium channel blockers)
10. untreated urinary tract infection
11. pregnant or breast feeding
12. neurological impairment or spinal cord injury
13. known hypersensitiviy to CyA
14. concurrent use of another immunosuppressive drug (eg. oral corticosteroids,
tacrolimus, mycophenolate mofetil)
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