NCT01302899

Brief Summary

The study is designed to primarily assess the effect of aliskiren on albuminuria in patients with non-diabetic nephropathy when treated with ramipril and volume intervention.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

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

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 30, 2013

Completed
Last Updated

January 30, 2013

Status Verified

December 1, 2012

Enrollment Period

11 months

First QC Date

February 9, 2011

Results QC Date

December 21, 2012

Last Update Submit

December 21, 2012

Conditions

Non-diabetic Nephropathy

Outcome Measures

Primary Outcomes (2)

  • Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)

    Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.

    26 weeks

  • Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin

    Two 24-hour collections of urine were to be made at each study visit. The arithmetic mean of the two collections were planned to be used in the calculation of summary statistics and the statistical analyses.

    26 weeks

Secondary Outcomes (9)

  • Mean Sitting Systolic Blood Pressure (msSBP)

    26 weeks

  • Mean Sitting Diastolic Blood Pressure (msDBP)

    26 weeks

  • Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function

    26 weeks

  • Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments

    26 weeks

  • Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments

    26 weeks

  • +4 more secondary outcomes

Study Arms (2)

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram

EXPERIMENTAL

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Drug: AliskirenDrug: Placebo to AliskirenDrug: Hydrochlorothiazide (HCTZ)Drug: Placebo to Hydrochlorothiazide (HCTZ)Drug: Ramipril

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram

EXPERIMENTAL

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d. Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d. Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d. Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Drug: AliskirenDrug: Placebo to AliskirenDrug: Hydrochlorothiazide (HCTZ)Drug: Placebo to Hydrochlorothiazide (HCTZ)Drug: Ramipril

Interventions

AliskirenDRUG

Aliskiren 150 mg (Tablet)

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/RamRamipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
Placebo to AliskirenDRUG

Aliskiren 150 mg Matching Placebo (Tablet)

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/RamRamipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
Hydrochlorothiazide (HCTZ)DRUG

HCTZ 25mg (Capsule)

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/RamRamipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
Placebo to Hydrochlorothiazide (HCTZ)DRUG

HCTZ 25mg (Capsule) Matching Placebo

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/RamRamipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
RamiprilDRUG

Ramipril 10mg (Tablet)

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/RamRamipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects, age 18 years and above
  • Patients with chronic kidney disease of non-diabetic origin
  • Glomerular filtration rate \>30 ml/min/1.73m2
  • Patients with a history of hypertension and msSBP (mean systolic blood pressure) of \<160 mm Hg and msDBP (mean diastolic blood pressure) \<105 mm Hg at screening and baseline.
  • Subjects must have a body mass index (BMI) within the range of 18 and 35 kg/m2

You may not qualify if:

  • Previously treated (within 3 months of screening) with aliskiren or a combination of aliskiren and ramipril.
  • Severe hypertension (msDBP ≥110 mmHg and msSBP ≥180 mmHg)
  • Pregnant or nursing (lactating) women,
  • A medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months
  • Diabetes mellitus, Heart failure
  • High rate of renal function loss
  • History of severe hypersensitivity or contraindications to any of the medications or drugs belonging to the similar therapeutic class as the study drugs and the excipients.
  • History of liver disease, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
  • History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Groningen, Netherlands

Location

Novartis Investigative Site

Leeuwarden, Netherlands

Location

MeSH Terms

Interventions

aliskirenHydrochlorothiazideRamipril

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 24, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 30, 2013

Results First Posted

January 30, 2013

Record last verified: 2012-12

Locations

NL(2)