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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626249
• Other study ID #: MKC-T-017
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2008
• Last updated: December 13, 2013
• Start date: August 2007
• Est. completion date: October 2008

Study information

• Verified date: December 2013
• Source: Mannkind Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 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 Technosphere® Inhalation Powder occurs at the dosing visit. (V2) with serum and urine PK testing .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Kidney Diseases
• Mild Nephropathy
• Moderate Nephropathy

Intervention

Drug:
• Technosphere Inhalation Powder
Technosphere Inhalation Powder

Locations

Country	Name	City	State
United States	Davita Clinical Research	Minneapolis	Minnesota
United States	Qualia Clinical Research	Omaha	Nebraska
United States	Diabetes & Glandular Disease Research Assoc PA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mannkind Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in exposure to fumaryl diketopiperazine (FDKP)		14 days	Yes
Secondary	Additional safety parameters		14 days	Yes