Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

This study has been completed.
Sponsor:
Collaborator:
Archimedes Development Ltd
Information provided by:
Pharmalink AB
ClinicalTrials.gov Identifier:
NCT00767221
First received: October 5, 2008
Last updated: April 20, 2009
Last verified: April 2009
  Purpose

The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56.


Condition Intervention Phase
IGA Nephropathy
Drug: Budesonide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

Resource links provided by NLM:


Further study details as provided by Pharmalink AB:

Primary Outcome Measures:
  • U-albumin [ Time Frame: 6(treatment)+3(follow-up) months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GFR and safety [ Time Frame: 6(treatment) + 3(follow-up) months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
The patient is his own control. Endpoint variables are measured before, during and after treatment.
Drug: Budesonide
8 mg PL-56 once daily for six months
Other Name: Nefecon, PL-56 (topical acting, anti-inflammatory agent)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Female or male patient > 18 years
  • Biopsy-verified IgA nephropathy
  • Proteinuria: U-albumin >500 mg/24 h
  • S-creatinine < 200 umol/L
  • A minimum of four available sample results (U-albumin and S-creatinine) prior to inclusion in the study.

Exclusion Criteria:

  • Severe gastrointestinal disorders which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the investigator
  • Consumption of an investigational drug within 30 days prior to enrolment
  • Unacceptable blood pressure (treated or untreated), defined as a systolic value >150 mm Hg and/or diastolic >90 mm Hg
  • Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
  • Patients in whom an ACE inhibitor was introduced/changed during the last three months prior to enrolment
  • Patients treated with immuno-suppressive drugs
  • Patients unable to take oral medication
  • Severe liver disease (defined as ASAT and/or ALAT and/or gamma-GT above twice the normal value).
  • Uncontrolled (treated or untreated) congestive heart failure as judged by the Investigator
  • Patients with diabetes
  • Patients with current malignancy or history of malignancy during the last three years
  • History or presence of psychological or psychiatric illness which may interfere with the patient´s ability to adhere to the protocol
  • Alcohol or drug abuse (present)
  • Patients unwilling to meet the requirements of the protocol
  • Other medical or social reasons for exclusion at the discretion of the Investigator
  • Use of drugs inhibiting the cytochrome P-450 enzyme CYP3A4 (including grape fruit juice)
  • Kidney transplanted patients
  • For women only: pregnant or breast feeding; unwilling to use adequate contraception during the study (only women of childbearing potential)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767221

Locations
Sweden
Linköping University Hospital
Linköping, Sweden
Huddinge University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Sponsors and Collaborators
Pharmalink AB
Archimedes Development Ltd
Investigators
Principal Investigator: Bengt Fellström, MD, PhD Uppsala University Hospital, Dept. of Medicine
  More Information

No publications provided

Responsible Party: Johan Häggblad, Pharmalink AB
ClinicalTrials.gov Identifier: NCT00767221     History of Changes
Other Study ID Numbers: U-03-003
Study First Received: October 5, 2008
Last Updated: April 20, 2009
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Budesonide
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 14, 2014