NCT01184599

Brief Summary

The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

June 27, 2011

Status Verified

May 1, 2010

Enrollment Period

2.8 years

First QC Date

August 16, 2010

Last Update Submit

June 23, 2011

Conditions

Glomerulonephritis, IGAHypertension

Keywords

AliskirenAlbuminuriaAngiotensinogencollagen type IVTransforming Growth Factor betaaldosteronereninprorenin receptordes-angiotensin I renin substrateoxidative stressadvanced glycosylation end-product receptorN,N-dimethylarginine

Outcome Measures

Primary Outcomes (2)

  • Renal function (Creatinine clearance)

    One year (every 6 months)

  • Urinary protein

    One year (every 6 months)

Secondary Outcomes (10)

  • Urinary angiotensinogen

    One year (every 6 months)

  • Urinary type 4 collagen

    One year (every 6 months)

  • Urinary Transforming growth factor-beta

    One year (every 6 months)

  • High-sensitivity C-reactive protein

    One year (every 6 months)

  • Plasma Rennin Activity

    One year (every 12 months)

  • +5 more secondary outcomes

Interventions

aliskirenDRUG

150 mg/day p.o.

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • IgA nephropathy confirmed by renal biopsy
  • Hypertension (\<= 125/75 mmHg)

You may not qualify if:

  • Patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks
  • Severe hypertension (\<= 180/110 mmHg) or secondary hypertension
  • Patients with history of allergy or adverse effect for aliskiren
  • Renal dysfunction (estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2)
  • Pregnancy
  • Patient treated with cyclosporine
  • Hyperkalemia (serum potassium \>= 5.6 mmol/L)
  • Autoimmune disease including systemic lupus erythematosus
  • Patients inadequate for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kurume University, School of Medicine

Fukuoka, 830-0011, Japan

RECRUITING

Department of Internal Medicine, Osaka City General Hospital

Osaka, 534-0021, Japan

RECRUITING

Ohno memorial Hospital

Osaka, 550-0015, Japan

NOT YET RECRUITING

Kinki University, Faculty of Medicine

Osaka, 589-8511, Japan

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGAHypertensionAlbuminuriaCamurati-Engelmann Syndrome

Interventions

aliskiren

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesVascular DiseasesCardiovascular DiseasesProteinuriaUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Masahito Imanishi

    Osaka City General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Masahito Imanishi

CONTACT

+81-6-6929-1221masachan@msic.med.osaka-cu.ac.jp

Hirofumi Hitomi

CONTACT

+81-87-891-2125hitomi@kms.ac.jp

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 19, 2010

Study Start

June 1, 2010

Primary Completion

March 1, 2013

Last Updated

June 27, 2011

Record last verified: 2010-05

Locations

JP(4)