Status:
COMPLETED
Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney Function
Lead Sponsor:
Mannkind Corporation
Conditions:
Mild Nephropathy
Moderate Nephropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
24 diabetics with mild \& moderate renal disease and 12 diabetics without renal disease. One screening, one dosing \& one follow-up visit with Technosphere® Inhalation Powder given at Visit 2 via Med...
Detailed Description
This Phase 1, single-dose trial is being conducted to determine if nephropathy affects the way the kidneys eliminate the byproducts of Technosphere® Inhalation Powder as compared to kidneys free of d...
Eligibility Criteria
Inclusion
- Non-smoking males and females, = 18 and = 80 years with a BMI of = 37 kg/m2
- Type 1 or type 2 diabetic
- Subjects with mild or moderate DNP and subjects with normal renal function, based on GFR rate and albuminuria
- Normal pulmonary function and performance based on PFTs
Exclusion
- No history of COPD, asthma, or active respiratory infection; must be able to perform PFTs
- No dose and/or formulation changes within the preceding 6 weeks for any concomitant medications
- No clinically significant major organ/systemic disease
- No previous or current chemotherapy or radiation therapy that may result in pulmonary toxicity
- No clinically significant abnormalities on screening laboratory evaluation, except abnormal laboratory renal parameters in subjects with DNP
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00626249
Start Date
August 1 2007
End Date
October 1 2008
Last Update
December 17 2013
Active Locations (3)
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1
Davita Clinical Research
Minneapolis, Minnesota, United States, 55404
2
Qualia Clinical Research
Omaha, Nebraska, United States, 68154
3
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, United States, 78229