Clinical trial NCT00626249: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mild Nephropathy
Moderate Nephropathy
Diabetes Mellitus
Keywords: Nephropathy
Kidney Disease
Diabetic
Renal
Diabetics
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 24 diabetics with mild \& moderate renal disease and 12 diabetics without renal disease. One screening, one dosing \& one follow-up visit with TechnosphereÂ® Inhalation Powder given at Visit 2 via MedToneÂ® Inhaler and PK testing at 26 designated time points

Detailed description: This Phase 1, single-dose trial is being conducted to determine if nephropathy affects the way the kidneys eliminate the byproducts of TechnosphereÂ® Inhalation Powder as compared to kidneys free of disease. This trial will test the safety, tolerability and pharmacokinetics of the study medication. The trial consists of a screening, dosing and a follow-up visit. Single dose administration of TechnosphereÂ® Inhalation Powder occurs at the dosing visit. (V2) with serum and urine PK testing .

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Differences in exposure to fumaryl diketopiperazine (FDKP)
timeFrame: 14 days
Secondary outcomes:
measure: Additional safety parameters
timeFrame: 14 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Davita Clinical Research
state: Minnesota
city: Omaha
country: United States
facility: Qualia Clinical Research
state: Nebraska
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Assoc PA
state: Texas
Study officials:
affiliation: Mannkind Corporation
name: Anders Boss
role: STUDY_DIRECTOR
References: