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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00626249

Enrollment

Registered

2008-02-29

Start date

2007-08-31

Completion date

2008-10-31

Last updated

2013-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus

Keywords

Nephropathy, Kidney Disease, Diabetic, Renal, Diabetics

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 .

Interventions

DRUGTechnosphere Inhalation Powder

Technosphere Inhalation Powder

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Differences in exposure to fumaryl diketopiperazine (FDKP)	14 days

Secondary

Measure	Time frame
Additional safety parameters	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026