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A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

K

Kagawa University

Status and phase

Unknown
Phase 4

Conditions

Glomerulonephritis, IGA
Hypertension

Treatments

Drug: aliskiren

Study type

Interventional

Funder types

Other

Identifiers

NCT01184599
OCGH-746

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

4

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Central trial contact

Hirofumi Hitomi; Masahito Imanishi

Data sourced from clinicaltrials.gov

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