Clinical trial for the research into changes in renal function of adolescent and adult patients with Glycogen storage disease type Ia. - HADUEGRO 2006

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000282-11-DE

Enrollment

Registered

2006-02-28

Start date

2006-08-17

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycogen storage disease type Ia

Interventions

Trade Name: ACE-Hemmer-ratiopharm 12,5 Product Name: Captopril Pharmaceutical Form: Tablet Trade Name: ACE-Hemmer-ratiopharm 25 Product Name: Captopril Pharmaceutical Form: Tablet Trade Name: AC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: diagnosis of GSD Ia (enzymatic or genetic) minimum 16 years old puberty completed consent of parient / parents Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: pregnancy acute intercurrent illness diagnosis of another chronic illness missing consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Effects of the substances on glomerular filtration rate. Patients with glycogen storage disease (GSD) type Ia show renal hyperfiltration early as a sign of beginning nephropathy. We want to explore the effect of 1. an angiotensinogen-converting-enzyme (ACE) and 2. a cyclooxygenase (COX) -inhibitor to show which substance has a greater benefit concerning reduction of the hyperfiltration. By doing this we will achieve a better understanding of the pathomechanism of GSD-nephropathy. ;Secondary Objective: Effects of the substances on metabolite-concentration in unrine.;Primary end point(s): three days evaluation of inulin-clearance (without medication / with ACE-inhibitor / with Indometacin)	—

Measure

Time frame

Main Objective: Effects of the substances on glomerular filtration rate. Patients with glycogen storage disease (GSD) type Ia show renal hyperfiltration early as a sign of beginning nephropathy. We want to explore the effect of 1. an angiotensinogen-converting-enzyme (ACE) and 2. a cyclooxygenase (COX) -inhibitor to show which substance has a greater benefit concerning reduction of the hyperfiltration. By doing this we will achieve a better understanding of the pathomechanism of GSD-nephropathy. ;Secondary Objective: Effects of the substances on metabolite-concentration in unrine.;Primary end point(s): three days evaluation of inulin-clearance (without medication / with ACE-inhibitor / with Indometacin)

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026