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

NCT00767221 | Completed Phase 2

• 1 other identifier: U-03-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

IGA Nephropathy

Outcome Measures

Primary Outcomes (1)

• U-albumin

  6(treatment)+3(follow-up) months

Secondary Outcomes (1)

• GFR and safety

  6(treatment) + 3(follow-up) months

Study Arms (1)

A

EXPERIMENTAL

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

Drug: Budesonide

Interventions

Budesonide DRUG

8 mg PL-56 once daily for six months

Also known as: Nefecon, PL-56 (topical acting, anti-inflammatory agent)

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Use of drugs inhibiting the cytochrome P-450 enzyme CYP3A4 (including grape fruit juice)

Sponsors & Collaborators

• Calliditas Therapeutics AB: lead
• Archimedes Development Ltd: collaborator

Study Sites (3)

Linköping University Hospital

Linköping, Sweden

Location

Huddinge University Hospital

Stockholm, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Budesonide; Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Bengt Fellström, MD, PhD

  Uppsala University Hospital, Dept. of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2008
• First Posted: October 7, 2008
• Study Start: October 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 21, 2009

Record last verified: 2009-04

Locations

SE (3)