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Completed

NCT Number: 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

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

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Key information

Conditions

Mild Nephropathy Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Moderate Nephropathy Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Davita Clinical Research, Minneapolis, Minnesota, United States

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technosphere Inhalation Powder

Drug

Technosphere Inhalation Powder

Primary outcomes

  1. Differences in exposure to fumaryl diketopiperazine (FDKP)

    Time frame: 14 days

Secondary outcomes

  1. Additional safety parameters

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Mannkind Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 29, 2008
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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