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
A Phase 1b, Single-Dose, Open Label, Parallel Design, Controlled Pharmacology Trial of Fumaryl Diketopiperazine Administered as Technosphere Inhalation Power in Subjects With Either Mild or Moderate Chronic Kidney Disease vs. Matched Subjects Without Chronic Kidney Disease
1 other identifier
interventional
36
1 country
3
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 MedTone® Inhaler and PK testing at 26 designated time points
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2007
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedDecember 17, 2013
December 1, 2013
1.1 years
February 21, 2008
December 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in exposure to fumaryl diketopiperazine (FDKP)
14 days
Secondary Outcomes (1)
Additional safety parameters
14 days
Study Arms (2)
T Inhalation powder in diabetic subjs w/ normal renal func
EXPERIMENTALT inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
T Inhalation powder diabetic subj w/mild or moderate nephrop
EXPERIMENTALT Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units
Interventions
Technosphere Inhalation Powder
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Davita Clinical Research
Minneapolis, Minnesota, 55404, United States
Qualia Clinical Research
Omaha, Nebraska, 68154, United States
Diabetes & Glandular Disease Research Assoc PA
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anders Boss
Mannkind Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2008
First Posted
February 29, 2008
Study Start
August 1, 2007
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
December 17, 2013
Record last verified: 2013-12