Clinical trial NCT00767221: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: IGA Nephropathy
Lead sponsor: Calliditas Therapeutics AB
Sponsor class: INDUSTRY
Collaborators: name: Archimedes Development Ltd
First posted: 2008-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: U-albumin
timeFrame: 6(treatment)+3(follow-up) months
Secondary outcomes:
measure: GFR and safety
timeFrame: 6(treatment) + 3(follow-up) months
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Stockholm
country: Sweden
facility: Huddinge University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital, Dept. of Medicine
name: Bengt Fellström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: