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

Primary Purpose

IGA Nephropathy

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Budesonide
Sponsored by
Calliditas Therapeutics AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IGA Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Linköping University Hospital
  • Huddinge University Hospital
  • Uppsala University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

The patient is his own control. Endpoint variables are measured before, during and after treatment.

Outcomes

Primary Outcome Measures

U-albumin

Secondary Outcome Measures

GFR and safety

Full Information

First Posted
October 5, 2008
Last Updated
April 20, 2009
Sponsor
Calliditas Therapeutics AB
Collaborators
Archimedes Development Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00767221
Brief Title
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
Official Title
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Calliditas Therapeutics AB
Collaborators
Archimedes Development Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IGA Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
The patient is his own control. Endpoint variables are measured before, during and after treatment.
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Nefecon, PL-56 (topical acting, anti-inflammatory agent)
Intervention Description
8 mg PL-56 once daily for six months
Primary Outcome Measure Information:
Title
U-albumin
Time Frame
6(treatment)+3(follow-up) months
Secondary Outcome Measure Information:
Title
GFR and safety
Time Frame
6(treatment) + 3(follow-up) months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bengt Fellström, MD, PhD
Organizational Affiliation
Uppsala University Hospital, Dept. of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Huddinge University Hospital
City
Stockholm
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

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

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