Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action

Interstitial Cystitis Clinical Trial

— CIC  

Official title:

Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990898
• Other study ID #: 13-1271
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2013
• Last updated: June 14, 2016
• Start date: November 2013
• Est. completion date: April 2016

Study information

• Verified date: October 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Drug:
• Cyclosporine
Drug will be provided to patient's at study visit. Drug is to be taken twice daily. Dosage will be calculated at study visit and provided to patient.

Locations

Country	Name	City	State
United States	Cleveland Clinic - Main Campus Only	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the effects of cyclosporine treatment on current perception and pain threshold using a Neurometer before, during and after treatment		3 Months	No